[Federal Register Volume 60, Number 173 (Thursday, September 7, 1995)]
[Proposed Rules]
[Pages 46718-46743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22027]
[[Page 46717]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 864, et al.
Medical Devices; Effective Date of Requirement for Premarket Approval
for Class III Preamendments Devices; Proposed Rules
Federal Register / Vol. 60, No. 173 / Thursday, September 7, 1995 /
Proposed Rules
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[[Page 46718]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 864, 868, 870, 872, 876, 880, 882, 884, 888, and 890
[Docket No. 95N-0084]
RIN 0910-AA31
Medical Devices; Effective Date of Requirement for Premarket
Approval for Class III Preamendments Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; opportunity to request a change in
classification.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of product development protocol (PDP) for 43 class III
medical devices. The agency also is summarizing its proposed findings
regarding the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the devices to meet the statute's
approval requirements and the benefits to the public from the use of
the devices. In addition, FDA is announcing the opportunity for
interested persons to request the agency to change the classification
of any of the devices based on new information.
DATES: Written comments by January 5, 1996; request for a change in
classification by September 22, 1995. FDA intends that, if a final rule
based on this proposed rule is issued, PMA's will be required to be
submitted within 90 days of the effective date of the final rule.
ADDRESSES: Submit written comments or requests for a change in
classification to the Dockets Management Branch (HFA-305), Food and
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4765.
SUPPLEMENTARY INFORMATION:
I. Background
Section 513 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360c) requires the classification of medical devices into
one of three regulatory classes: Class I (general controls), class II
(special controls), and class III (premarket approval). Generally,
devices that were on the market before May 28, 1976, the date of
enactment of the Medical Device Amendments of 1976 (the amendments)
(Pub. L. 94-295), and devices marketed on or after that date that are
substantially equivalent to such devices, have been classified by FDA.
For the sake of convenience, this preamble refers to both the devices
that were on the market before May 28, 1976, and the substantially
equivalent devices that were marketed on or after that date as
``preamendments devices.''
Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. A preamendments class III
device may be commercially distributed without an approved PMA or
notice of completion of a PDP until 90 days after FDA issues a final
rule requiring premarket approval for the device, or 30 months after
final classification of the device under section 513 of the act,
whichever is later. Also, a preamendments device subject to the
rulemaking procedure under section 515(b) of the act is not required to
have an approved investigational device exemption (IDE) (21 CFR part
812) contemporaneous with its interstate distribution until the date
identified by FDA in the final rule requiring the submission of a PMA
for the device. At that time, an IDE is required only if a PMA has not
been submitted or a PDP completed.
Section 515(b)(2)(A) of the act provides that a proceeding to issue
a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
proposed rule; (2) proposed findings with respect to the degree of risk
of illness or injury designed to be eliminated or reduced by requiring
the device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
Section 515(b)(2)(B) of the act provides that if FDA receives a
request for a change in the classification of the device within 15 days
of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change of
classification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the act. If FDA does not
initiate such a proceeding, section 515(b)(3) of the act provides that
FDA shall, after the close of the comment period on the proposed rule
and consideration of any comments received, issue a final rule to
require premarket approval, or publish a notice terminating the
proceeding. If FDA terminates the proceeding, FDA is required to
initiate reclassification of the device under section 513(e) of the
act, unless the reason for termination is that the device is a banned
device under section 516 of the act (21 U.S.C. 360f).
If a proposed rule to require premarket approval for a
preamendments device is made final, section 501(f)(2)(B) of the act (21
U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a
PDP for any such device be filed within 90 days of the date of
promulgation of the final rule or 30 months after final classification
of the device under section 513 of the act, whichever is later. If a
PMA or a notice of completion of a PDP is not filed by the later of the
two dates, commercial distribution of the device is required to cease.
The device may, however, be distributed for investigational use if the
manufacturer, importer, or other sponsor of the device complies with
the IDE regulations. If a PMA or a notice of completion of a PDP is not
filed by the later of the two dates, and no IDE is in effect, the
device is deemed to be adulterated within the meaning of section
501(f)(1)(A) of the act, and subject to seizure and condemnation under
section 304 of the act (21 U.S.C. 334) if its distribution continues.
Shipment of the device in interstate commerce will be subject to
injunction under section 302 of the act (21 U.S.C. 332), and the
individuals responsible for such shipment will be subject to
prosecution under section 303 of the act (21 U.S.C. 333). In the past,
FDA has requested that manufacturers take action to prevent the further
use of devices for which no PMA has been filed and may determine that
such a request is appropriate for the class III devices that are the
subjects of this regulation.
The act does not permit an extension of the 90-day period after
promulgation of a final rule within which an application or a notice is
required to be filed. The House Report on the amendments states that
``the thirty month `grace period' afforded after classification of a
device into class III * * * is sufficient time for manufacturers and
importers to develop the data and conduct the investigations necessary
to support an application for premarket
[[Page 46719]]
approval.'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976).)
The Safe Medical Devices Act of 1990 (Pub. L. 101-629) (SMDA) added
new section 515(i) to the act (21 U.S.C. 360e(i)). This section
requires FDA to review the classification of preamendments class III
devices for which no final rule has been issued requiring the
submission of PMA's and to determine whether each device should be
reclassified into class I or class II or remain in class III. For
devices remaining in class III, SMDA directed FDA to develop a schedule
for issuing regulations to require premarket approval. However, the
SMDA does not prevent FDA from proceeding immediately to rulemaking
under section 515(b) of the act on specific devices, in the interest of
public health, independent of the procedures in section 515(i). Indeed,
proceeding directly to rulemaking under section 515(b) of the act is
consistent with Congress' objective in enacting section 515(i) i.e.,
that preamendments class III devices for which PMA's have not been
required either be reclassified to class I or class II or be subject to
the requirements of premarket approval. Moreover, in this proposal,
interested persons are being offered the opportunity to request
reclassification of any of the devices.
In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a
notice of availability of a preamendments class III devices strategy
document. The strategy document set forth FDA's plans for implementing
the provisions of section 515(i) of the act for preamendments class III
devices for which FDA had not yet required premarket approval. FDA
divided this universe of devices into three groups:
1. Group 1 devices are devices that FDA believes raise significant
questions of safety and/or effectiveness but are no longer used or are
very limited in use. FDA's strategy is to call for PMA's for all Group
1 devices in an omnibus 515(b) rulemaking action. This proposed rule
implements that strategy and covers all Group 1 devices referenced by
the May 6, 1994, Federal Register notice.
2. Group 2 devices are devices that FDA believes have a high
potential for being reclassified into class II. For these devices, FDA
has issued an order under section 515(i) of the act requiring
manufacturers to submit safety and effectiveness information so that
FDA can make a determination as to whether the devices should be
reclassified.
3. Group 3 devices are devices that FDA believes are currently in
commercial distribution and are not likely candidates for
reclassification. FDA intends to issue proposed rules to require the
submission of PMA's for the 15 highest priority devices in this group
in accordance with the schedule set forth in the strategy document. FDA
has also issued an order under section 515(i) of the act for the
remaining 27 Group 3 devices requiring the submission of safety and
effectiveness information so that FDA can make a determination as to
whether the devices should be reclassified or retained in class III.
A. Dates New Requirements Apply
In accordance with section 515(b) of the act, FDA is proposing to
require that a PMA or a notice of completion of a PDP be filed with the
agency for class III devices within 90 days after promulgation of any
final rule based on this proposal. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found by FDA to be substantially equivalent to such a device,
will be permitted to continue marketing such class III devices during
FDA's review of the PMA or notice of completion of the PDP. FDA intends
to review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act,
the agency may not enter into an agreement to extend the review period
for a PMA beyond 180 days unless the agency finds that ``* * * the
continued availability of the device is necessary for the public
health.''
FDA intends that, under Sec. 812.2(d) (21 CFR 812.2(d)), the
preamble to any final rule based on this proposal will state that, as
of the date on which a PMA or a notice of completion of a PDP is
required to be filed, the exemptions in Sec. 812.2(c)(1) and (c)(2)
from the requirements of the IDE regulations for preamendments class
III devices will cease to apply to any device that is: (1) Not legally
on the market on or before that date, or (2) legally on the market on
or before that date but for which a PMA or notice of completion of PDP
is not filed by that date, or for which PMA approval has been denied or
withdrawn.
If a PMA or a notice of completion of a PDP for a class III device
is not filed with FDA within 90 days after the date of promulgation of
any final rule requiring premarket approval for the device, commercial
distribution of the device must cease. The device may be distributed
for investigational use only if the requirements of the IDE regulations
regarding significant risk devices are met. The requirements for
significant risk devices include submitting an IDE application to FDA
for its review and approval. An approved IDE is required to be in
effect before an investigation of the device may be initiated or
continued. FDA, therefore, cautions that IDE applications should be
submitted to FDA at least 30 days before the end of the 90-day period
after the final rule to avoid interrupting investigations.
B. Proposed Finding With Respect to Risks and Benefits
As required by section 515(b) of the act, FDA is publishing its
proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA or a declared completed PDP; and (2) the
benefits to the public from the use of the device.
These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with any additional information that FDA discovers. Additional
information can be found in the proposed and final rules classifying
these devices as listed below:
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Devices--- Proposed rule- Final rule
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Hematology/Pathology September 11, 1979 (44 September 12, 1980 (45
(21 CFR part 864). FR 52950). FR 60576
Anesthesiology 1982 (21 November 2, 1979 (44 FR July 16, (47 FR 31130)
CFR part 868). 63292).
Cardiovascular (21 CFR March 9, 1979- (44 FR February 5, 1980 (45
part 870). 13284). FR 7904)
Dental (21 CFR part December 30, 198 (45 FR August 12, 1987 (52 FR
872). 85962). 30082)
Gastroenterology- January 23, 1981 (46 FR November 23, 1983 (48
Urology (21 CFR part 7562). FR 53012)
876).
General Hospital and August 24, 1979 (44 FR October 21, 1980 (45
Personal Use (21 CFR 49844). FR 69678)
part 880).
Neurological (21 CFR November 28, 1978 (43 September 4, 1979 (44
part 882). FR 55640). FR 51726)
Obstetrical and April 3, 1979-(44 FR February 26, 1980 (45
Gynecological. 19894). FR 12682)
[[Page 46720]]
Orthopedic (21 CFR part July 2, 1982 (47 FR September 4, 1987 (52
888). 29052). FR 33686)
Physical Medicine (21 August 28, 1979 (44 FR November 23, 1983 (48
CFR part 890). 50458). FR 53032)
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C. Devices Subject to This Proposal
1. Hematology and Pathology Devices
Automated Differential Cell Counter (Sec. 864.5220)
(1) Identification. An automated differential cell counter is a
device used to identify and classify one or more of the formed elements
of the blood. The device is in class III when intended for uses other
than to flag or identify specimens containing abnormal blood cells.
Otherwise, the device is in class II.
(2) Summary of data. The members of the Hematology and Pathology
Devices Classification Panel based their recommendation upon the Panel
members' clinical experience with automated differential cell counters
and on information presented at a symposium entitled ``Differential
Counters in Hematology'' held at the Panel meeting. Among the speakers
at the symposium was Dr. Robert Miller of the Johns Hopkins University
Medical Center. Dr. Miller discussed difficulties concerning data
interpretation, precision and accuracy, correlation to reference
methods and error in terms of coincidence, nonreproducible results,
nonlinearity, and specific interferences.
FDA has reviewed medical literature concerning automated
differential cell counters (Refs. 1 through 5). The medical literature
reports two basic methodologies for automated differential cell
counting: Pattern recognition and flow-through techniques. Pattern
recognition systems microscopically scan a fixed, stained blood film.
Flow-through systems count and identify cells suspended in a liquid
medium.
Pattern recognition systems are handicapped by their lack of
accuracy (Ref. 1). In one study, 68.8 percent of the abnormal cells
that the system examined were classified as normal (Ref. 2). An error
of this sort could result in the failure to detect a pathological blood
sample (Ref. 1). Several studies (Refs. 3 through 5) show a discrepancy
between pattern recognition counts and manual counts of monocytes
(mononuclear leukocytes). It is suggested that the criteria for
identifying monocytes need to be better defined (Ref. 4). There also
have been reports of discrepancies between pattern recognition counts
and manual counts of plasma cells and atypical lymphocytes (Ref. 4).
The tendency of pattern recognition systems to underestimate the number
of atypical lymphocytes is ascribed to flaws in the recognition
criteria. Pattern recognition systems also cause difficulty in blood
film preparation. Overlapping cells must be avoided, and a uniform
distribution of cell types must be achieved (Ref. 1).
Flow-through systems allow a hundredfold increase in the rate at
which cells are counted. There is imperfect correlation between the
classification logic systems of the flow-through machines and
morphological features of the blood cell classes as defined by fixed,
Romanowsky-stained preparations (Ref. 1). Therefore, these machines
will fail to classify up to 10 percent of normal cells.
The device was the subject of a reclassification petition and was
partially reclassified into class II for the uses listed above. The
proposed rule for reclassification was published in the Federal
Register of April 5, 1989 (54 FR 13698) and the final rule was
published in the Federal Register of June 8, 1990 (55 FR 23510).
(3) Risks to health.
Hepatitis infection--Exposure of the user, donor, or
patient to blood, blood products, or blood aerosols presents a risk of
hepatitis infection. HIV was unknown in 1979 when the device was
classified and is also an important risk.
Misdiagnosis and inappropriate therapy--Failure of the
device to perform satisfactorily may lead to an error in the diagnosis
of a blood cell disorder. Inappropriate therapy based on inaccurate
diagnostic data may place the patient at risk.
2. Anesthesiology Devices
Electroanesthesia Apparatus (Sec. 868.5400)
(1) Identification. An electroanesthesia apparatus is a device used
for the induction and maintenance of anesthesia during surgical
procedures by means of an alternating or pulsed electric current that
is passed through electrodes fixed to the patient's head.
(2) Summary of data. The Anesthesiology Devices Classification
Panel and the Neurological Devices Classification Panel recommended
that electroanesthesia apparatus be classified into class III
(premarket approval) because the device presents a potential
unreasonable risk of illness or injury to the patient. The
Anesthesiology Devices Classification Panel based its recommendation on
the insufficient number of domestic studies on human subjects. The
Panel had not seen any medical data on which to judge the safety and
effectiveness of the device, and believed that the technique of
electroanesthesia is not considered a well-established or well-
recognized clinical procedure. The Neurological Devices Classification
Panel noted that many factors important to the clinical application of
this technique have not been sufficiently defined. The Neurological
Devices Classification Panel also based its recommendation on the Panel
members' experience with the device, and their judgment and knowledge
of the pertinent literature (Ref. 6). The National Research Council
recommended that electroanesthesia should be considered as a
potentially useful adjunct in the maintenance of anesthesia but that
electroanesthesia should be limited to investigational use until its
effects, advantages, and standardization can be adequately evaluated.
(3) Risks to health.
Electrical shock--Improper electrical grounding may allow
the patient or operator to receive an electrical shock.
Damage to central nervous system--Excessively high
electrical current or voltage could damage the central nervous system
and cerebral tissues.
Skin burns--If the electrodes are too small and yield a
high current density, skin burns may result.
Skin irritation--Electrode gels or pastes used to
establish electrical contact between the electrode and the skin may
cause skin irritation.
Cardiac or pulmonary interference--The position of the
electrode on the head may lead to electrical interference with cardiac
or pulmonary functions in the patient.
3. Cardiovascular Devices
Catheter Balloon Repair Kit (Sec. 870.1350)
(1) Identification. A catheter balloon repair kit is a device used
to repair or replace the balloon of a balloon catheter. The kit
contains the materials, such as glue and balloons, necessary to effect
the repair or replacement.
(2) Summary of data. The members of the Cardiovascular Devices
Classification Panel based their recommendation on the potential
hazards associated with the inherent properties of the device and on
their personal knowledge of, and experience with, the device. The Panel
was not aware of any published literature on this device.
[[Page 46721]]
(3) Risks to health.
Gas embolism--Balloon rupture caused by the repair
material or a leak in the repair material can allow potentially
debilitating or fatal gas emboli to escape into the bloodstream. -
Embolism--Pieces of the balloon that break or flake off
may form potentially debilitating or fatal emboli.
Thromboembolism--Inadequate blood compatibility of the
materials used in this device and inadequate surface finish and
cleanliness can lead to potentially debilitating or fatal
thromboemboli.
Cardiac arrhythmias--Toxic substances released from the
repair material (glue or other adhesive) can trigger cardiac
arrhythmias (irregularities in heart rhythm).
Trace Microsphere (Sec. 870.1360)
(1) Identification. A trace microsphere is a radioactively tagged
nonbiodegradable particle that is intended to be injected into an
artery or vein and trapped in the capillary bed for the purpose of
studying blood flood within or to an organ.
(2) Summary of data. The Panel members based their recommendation
on the potential hazards associated with the inherent properties of the
device and on their personal knowledge of, and experience with, the
device.
(3) Risks to health.
Thromboembolism--Inadequate blood compatibility of the
materials used in the device may lead to potentially debilitating or
fatal thromboemboli.
Embolism--If the microspheres are too large or tend to
clump together, they can lodge in a blood vessel and block the flow of
blood to an organ.
Tissue damage--Tissue damage can result from excessive
radioactivity of the particles.
Carotid Sinus Nerve Stimulator (Sec. 870.3850)
(1) Identification. A carotid sinus nerve stimulator is an
implantable device used to decrease arterial pressure by stimulating
Hering's nerve at the carotid sinus.
(2) Summary of data. The Panel members based their recommendation
on the potential hazards associated with the inherent properties of the
device and on their personal knowledge of, and experience with, the
device.
(3) Risks to health.
Tissue and blood damage--If the materials, surface finish,
or cleanliness of this device are inadequate, damage to the blood and
tissue may result.
Inability to control blood pressure--Failure of the device
to stimulate properly can prevent effective control of elevated blood
pressure.-
High-Energy DC-Defibrillator (Including Paddles) (Sec. 870.5300)
(1) Identification. A high-energy DC-defibrillator is a device that
delivers into a 50-ohm test load an electrical shock of greater than
360 joules of energy used for defibrillating the atria or ventricles of
the heart or to terminate other cardiac arrhythmias. The device may
either synchronize the shock with the proper phase of the
electrocardiogram or may operate asynchronously. The device delivers
the electrical shock through paddles placed either directly across the
heart or on the surface of the body.
(2) Summary of data. The Panel relied upon the potential hazards
associated with the inherent properties of the device and on the Panel
members' personal knowledge of, and experience with, the device. In
addition, the Panel sought information from the medical and scientific
community, industry, and medical literature (Refs. 20 through 25).
(3) Risks to health.
Electrical shock to operator--Improper electrical design
of the device can lead to a serious electrical shock to the operator.
Inability to defibrillate or persistence of the
arrhythmia--Inability to rhythmia may occur because of excessive
energy, excessive current, insufficient energy, insufficient current, a
difference between the indicated level of energy and the delivered into
a 50-ohm load, or excessive leakage current. -
Inability to defibrillate--Inability to defibrillate may
occur when certain drugs that can raise the defibrillation threshold
are used.
Inability to defibrillate due to paddle design--Inability
to defibrillate may result from inappropriate paddle size or
inappropriate paddle location on the subject.
4. Dental Devices
Karaya and Sodium Borate With or Without Acacia Denture Adhesive
(Sec. 872.3400)
(1) Identification. A karaya with sodium borate with or without
acacia denture adhesive is a device composed of karaya and sodium
borate with or without acacia intended to be applied to the base of a
denture before the denture is inserted into the patient's mouth. The
device is used to improve denture retention and comfort. If it contains
12 percent or more by weight of sodium borate, it is in class III;
otherwise it is in class I.
(2) Summary of data. The members of the Dental Devices
Classification Panel relied upon their personal knowledge of, and
clinical experience with, the device in the practice of dentistry and
on a report from the then-Bureau of Drugs' OTC Panel on Dentifrices and
Dental Care Agents (Ref. 26). This report states that there is a lack
of information concerning the safety of adhesives containing sodium
borate and a lack of information concerning the effectiveness of acacia
in denture adhesives. The report states that the sodium borate
concentration of 12 to 20 percent of the adhesive's total weight is
equivalent to 2.6 to 5.3 percent boron. Because at least a portion of a
denture adhesive is ingested, this amount of boron could cause chronic
toxicity in denture wearers (Ref. 27). The Panel agrees that there is a
lack of data concerning the safety and effectiveness of acacia and
karaya with sodium borate.
(3) Risks to health.
Chronic toxicity--The boron in this device may cause
chronic toxicity to users.
Adverse tissue reaction--If the materials in the device
are not biocompatible, the patient may have an adverse tissue reaction.
Carboxymethylcellulose Sodium and Cationic Polyacrylamide Polymer
Denture Adhesive (Sec. 872.3420)
(1) Identification. A carboxymethylcellulose sodium and cationic
polyacrylamide polymer denture adhesive is a device composed of
carboxymethylcellulose sodium and cationic polyacrylamide polymer
intended to be applied to the base of a denture before the denture is
inserted in a patient's mouth. The device is used to improve denture
retention and comfort.
(2) Summary of data. The Panel based its recommendation on the lack
of information available to demonstrate the effectiveness of
carboxymethylcellulose sodium and cationic polyacrylamide in dental
adhesives and on a report of the then-Bureau of Drugs' OTC Panel on
Dentifrices and Dental Care Agents. According to the report, the belief
that carboxymethylcellulose sodium is safe is based, in part, on its
widespread use in food products such as milk and ice cream (Ref. 28).
Tests of cationic polyacrylamide for acute oral toxicity, eye
irritation, and dermal and inhalation toxicity in subacute and chronic
feeding experiments in animals have been negative (Ref. 26). Human
patch tests also have been negative (Ref. 28). However, no data were
submitted to the Panel to demonstrate, and the literature did not
establish, the effectiveness of carboxymethylcellulose
[[Page 46722]]
sodium cationic polyacrylamide polymer as a denture adhesive.
(3) Risks to health.
Bone loss from lack of effectiveness--If the adhesive
fails to anchor the denture in its proper position, a change in the
distance between the upper and lower jaws may occur that may lead to
gum irritation and bone loss due to alteration of biting forces.
Adverse tissue reaction--if the materials in the device
are not biocompatible, the patient may have an adverse tissue reaction.
Polyacrylamide Polymer (Modified Cationic Denture Adhesive
(Sec. 872.3480)
(1) Identification. A polyacrylamide polymer (modified cationic)
denture adhesive is a device composed of polyacrylamide polymer
(modified cationic) intended to be applied to the base of a denture
before the denture is inserted in a patient's mouth. The device is used
to improve denture retention and comfort.
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with,
this device, and on a report of the then-Bureau of Drugs' OTC Panel on
Dentifrices and Dental Care Agents. Tests of polyacrylamide polymer
(modified cationic) for acute oral toxicity, eye irritation, and dermal
and inhalation toxicity in subacute and chronic feeding experiments in
animals have been negative (Ref. 26). Human patch tests also have been
negative (Ref. 28). However, no data were submitted to the Panel to
demonstrate, and the literature did not establish, the effectiveness of
polyacrylamide polymer as the sole ingredient of a denture adhesive.
(3) Risks to health.
Bone loss--If the adhesive fails to anchor the denture in
its proper position, and the distance between the upper and lower jaw
is changed, then bone loss and gum irritation may occur.
Adverse tissue reaction--If the materials in the device
are not biocompatible, the patient may have an adverse tissue reaction.
Polyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, and
Carboxymethylcellulose Sodium (NACMC) Denture Adhesive (Sec. 872.3500)
(1) Identification. Polyvinylmethylether maleic anhydride (PVM-MA),
acid copolymer, and carboxymethylcellulose sodium (NACMC) denture
adhesive is a device composed of polyvinylmethylether maleic anhydride,
acid copolymer, and carboxymethylcellulose sodium intended to be
applied to the base of a denture before the denture is inserted in a
patient's mouth. The device is used to improve denture retention and
comfort.
(2) Summary of data. The Panel based it recommendation on the Panel
members' personal knowledge of, and clinical experience with the device
and on a report of the then-Bureau of Drugs' OTC Panel on Dentifrices
and Dental Care Agents. The report states that sufficient data are not
available to demonstrate the safety and effectiveness of a combination
of PVM--MA and NACMC used as a denture adhesive (Ref. 26). The Panel
also based its recommendation on a publication by Blacow (Ref. 27),
which states that the pH and stability of the anhydride and diacid
forms may be hazardous due to the possible presence of an acid pH of 2
to 3, which can burn the tissues in the mouth.
(3) Risks to health.
Toxicity--Ingestion of the materials in this device may
cause chronic toxicity to users.
Adverse tissue reaction--If the materials in the device
are not biocompatible, the patient may have an adverse tissue reaction.
Acidity of the adhesive may burn tissues in the mouth.
Over-the-Counter (OTC) Denture Reliner (Sec. 872.3560)
(1) Identification. An OTC denture reliner is a device consisting
of a material such as plastic resin that is intended to be applied as a
permanent coating or lining on the base or tissue-contacting surface of
a denture. The device is intended to replace a worn denture lining and
may be available for purchase over the counter.
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device. The Panel also based its recommendation on statements that
further studies are necessary to determine the safety and effectiveness
of this device (Ref. 26).
(3) Risks to health.
Bone degeneration--Use of the device may cause alteration
in the vertical dimension of a denture and result in bone degeneration
in the upper and lower jaw.
Carcinomas--Long-term irritation or oral tissues caused by
incorrect vertical dimension may cause formation of carcinomas.
Root Canal Filling Resin (Sec. 872.3820)
(1) Identification. A root canal filling resin is a device composed
of material, such as methylmethacrylate, intended for use during
endodontic therapy to fill the root canal of a tooth. If chloroform is
used as an ingredient in the device, the device is in class III.
Otherwise, it is in class I.
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with,
root canal filling resins in the practice of dentistry.
(3) Risks to health. FDA believes that root canal fillings
containing chloroform present a risk of carcinogenicity.
5. Gastroenterology-Urology Devices
Colonic Irrigation System (Sec. 876.5220)
(1) Identification. A colonic irrigation system is a device
intended to instill water into the colon through a nozzle inserted into
the rectum to cleanse (evacuate) the contents of the lower colon. The
system is designed to allow evacuation of the contents of the colon
during the administration of the colonic irrigation. The device
consists of a container for fluid connected to the nozzle via tubing
and includes a system which enables the pressure, temperature, or flow
of water through the nozzle to be controlled. The device may include a
console-type toilet and necessary fittings to allow the device to be
connected to water and sewer pipes. The device may use electrical power
to heat the water. This device does not include the enema kit
(Sec. 876.5210). When the device is intended for colon cleansing when
medically indicated, such as before radiologic or endoscopic
examinations, it is in class II. When the device is intended for other
uses, including colon cleansing routinely for general well being, it is
in class III.
(2) Summary of data. The members of the Gastroenterology-Urology
Devices Classification Panel based their recommendation on the Panel
members' personal knowledge of, and clinical experience with, the
device.
(3) Risks to health.
Tissue burns--The temperature-regulating mechanism for the
water heater used in this device may allow overheating of the water
which is delivered to the patient's colon, resulting in tissue burns.
Perforation of the colon--Excessive water pressure
delivered by this device could result in perforation of the wall of the
colon.
Colon irritation--Excessive or inappropriate use of this
device may result in irritation of the colon.
Electrical injury--Improper design, construction, or a
malfunction of the device could result in electrical injury to the
patient or operator.
[[Page 46723]]
Implanted Electrical Urinary Continence Device (Sec. 876.5270)
(1) Identification. An implanted electrical urinary continence
device is a device intended for treatment of urinary incontinence that
consists of a receiver implanted in the abdomen with electrodes for
pulsed-stimulation that are implanted either in the bladder wall or in
the pelvic floor, and a battery-powered transmitter outside the body.
(2) Summary of data. The Panel based its recommendation on a review
of the historical data concerning implanted electrical urinary
continence devices. Halverstadt and Parry (Ref. 29) discussed several
unsolved problems inherent in the electrical stimulation of the
bladder. These problems include breakage of lead wires, the cumbersome
nature of the electrodes, risk of preformation by wires of the bladder
cavity, difficulty of obtaining uniform contraction of the detrusor
muscle, and the spread of the stimulus to neighboring tissues producing
abdominal pain. The Panel also based its recommendation on the
experimental nature of these devices and on the lack of adequate
medical literature and experience supporting their safety and
effectiveness.
(3) Risks to health.
Adverse tissue reaction and erosion--Defects in the design
or the construction of the device, or lack of biocompatibility of the
materials used in the device, may cause an adverse tissue reaction and
tissue erosion adjacent to the device.
Infection--Defects in the design or construction of the
device preventing adequate cleaning or sterilization, or defects in
packaging or processing of a device sold as sterile, may allow
pathogenic organisms to be introduced and cause an infection in the
patient.
Tissue damage--Defects in the electrode wires may lead to
their breakage and consequent tissue damage.
Abdominal and leg pain--The amount of stimulation by the
electrodes necessary to obtain adequate bladder stimulation may lead to
abdominal and leg pain.
Electrical injury--Improper design, construction, or
malfunction of the device could result in electrical injury to the
patient or the operator.
6. General Hospital and Personal Use Devices
Chemical Cold Pack Snakebite Kit (Sec. 880.5760)
(1) Identification. A chemical cold pack snakebite kit is a device
consisting of a chemical cold pack and tourniquet used for first-aid
treatment of snakebites.
(2) Summary of data. The members of the General Hospital and
Personal Use Devices Classification Panel based their recommendation on
the Panel members' personal knowledge of, and clinical experience with,
the device and on several articles in the literature that evaluate
different types of treatment for snakebites (Refs. 30, 31, and 32).
Most of the literature showed that cryotherapy (the use of cold therapy
for the treatment of snakebites) is inappropriate. Clement and
Pietrusko found high rates of amputation, local tissue destruction, and
prolonged disability in patients treated by this method (Ref. 30). A
National Academy of Sciences report stated that doubts about the safety
and effectiveness of short-term cold therapy for treatment of
snakebites have not been resolved (Ref. 31). The report also stated
that the use of cold therapy for a long period of time appears to be
dangerous. Watt reported that, among children who had to have
amputations because of snakebites, 75 percent had received cryotherapy
for the snakebites (Ref. 32).
(3) Risks to health.
Local tissue damage--Exposure of tissue to cold
temperatures for long periods of time can freeze the tissue and cause
local tissue damage, sometimes necessitating limb amputations.
7. Neurological Devices
Rheoencephalograph (Sec. 882.1825)
(1) Identification. A rheoencephalograph is a device used to
estimate a patient's cerebral circulation (blood flow in the brain) by
electrical impedance methods with direct electrical connections to the
scalp or neck area.
(2) Summary of data. The members of the Neurological Devices
Classification Panel referenced the literature on this device (Refs. 43
through 46). Some of the panel members witnessed its clinical
application. Dr. William Jarzembski, one of the Panel members, provided
some detailed information concerning his research on this device.
(3) Risks to health.
Erroneous clinical conclusions--The device may indicate
that cerebral circulation is normal, when in fact it may be very
abnormal.
Electrical shock--Excessive current could cause injury,
and malfunction of the device could result in an electrical shock.
Skin reaction--The electrode materials and conductive
media may irritate the skin.
Intravascular Occluding Catheter (Sec. 882.5150)
(1) Identification. An intravascular occluding catheter is a
catheter with an inflatable or detachable balloon tip that is used to
block a blood vessel to treat malformations, e.g., aneurysms
(balloonlike sacs formed on blood vessels) of intracranial blood
vessels.
(2) Summary of data. The Panel members based their recommendation
on the lack of data available on this device. Although the Panel
members were aware of the use of this device in investigational
programs, they believed that there is not enough information or data to
demonstrate that its safety and effectiveness can be adequately
controlled by means other than premarket approval.
(3) Risks to health.
Infarction of nervous tissue--If the catheter is not
controllable or if the balloon or tip should fail or unexpectedly come
loose from the catheter, use of the device may cause infarction of
nervous tissue (death of nervous tissue due to stoppage of circulation)
and other serious injury to the brain and other nervous tissue.
Hemorrhage--The catheter or improper balloon inflation may
injure a blood vessel and result in bleeding.
Thrombogenesis--Blood coagulation and clotting may result
if the material of which the catheter is constructed is not compatible
with blood.
Implanted Spinal Cord Stimulator for Bladder Evacuation (Sec. 882.5850)
(1) Identification. An implanted spinal cord stimulator for bladder
evacuation is an electrical stimulator used to empty the bladder of a
paraplegic patient who has a complete transection of the spinal cord
and who is unable to empty his or her bladder by reflex means or by the
intermittent use of catheters. The stimulator consists of an implanted
receiver with electrodes that are placed on the conus medullaris
portion of the patient's spinal cord and an external transmitter for
transmitting the stimulating pulses across the patient's skin to the
implanted receiver.
(2) Summary of data. The Panel members based their recommendation
on information supplied by Dr. Blaine Nashold, one of the Panel
members, who had been one of the primary individuals engaged in the
development of the device (Ref. 37). Dr. Nashold reported that he had
implanted the device in a small group of paraplegic patients. Six of
the 12 patients had been successfully emptying their bladders by this
method for 5 years (Ref. 37).
(3) Risks to health.
[[Page 46724]]
Injury to neural tissue--Tissue fibrosis may develop
around the electrode on the spinal cord and cause a diminished response
to the electrical stimulus.
Tissue toxicity--The implanted stimulator, lead wires, or
electrodes may contain material that is not biocompatible.
Cerebrospinal fluid leakage--The fluid that surrounds the
spinal cord might leak out around the receiver wires.
8. Obstetrical and Gynecological Devices
Obstetric Data Analyzer (Sec. 884.2050)
(1) Identification. An obstetric data analyzer is a device designed
to interpret fetal status during labor and to warn of possible fetal
distress by analyzing electronic signal data obtained from fetal or
maternal electronic or other monitors. This generic type of device
includes signal analysis and display equipment, electronic interfaces
for other equipment, and power supplies and component parts.
(2) Summary of data. FDA reviewed the Obstetrical and Gynecological
Devices Classification Panel's recommendation and obtained additional
information and data describing the application of automatic analysis
techniques to the determination of possible fetal distress. The
technique was new in 1978, and very little definitive information was
available. It was reasonable to expect that as algorithms were
developed and tested, confidence in automatic analysis would increase
(Ref. 38).
(3) Risks to health.
Electrical shock--Malfunction of the device could result
in electrical shock to the patient.
Misdiagnosis--Inadequate design or calibration of the
device could lead to the generation of inaccurate diagnostic data. If
inaccurate diagnostic data is used in managing the patient, the
physician may prescribe a course of treatment which places the fetus
and patient at risk unnecessarily.
Fetal Electroencephalographic Monitor (Sec. 884.2620)
(1) Identification. A fetal electroencephalographic monitor is a
device used to detect, measure, and record in graphic form (by means of
one or more electrodes placed transcervically on the fetal scalp during
labor) the rhythmically varying electrical skin potentials produced by
the fetal brain.
(2) Summary of data. The Panel based its recommendation on the fact
that fetal electroencephalographic monitoring was a relatively new
method of brain function evaluation during birth. Its sensitivity and
applicability in the field of the fetal brain research remained to be
established because clinical experience was too limited to ascertain
its safe and effective use. Rosen and Peltzman, who were performing the
major research on this device, were continuing with further controlled
studies (Refs. 39 and 40).
(3) Risks to health.
Electrical shock--Malfunction of the device could result
in electrical shock to the patient.
Misdiagnosis--Inadequate design of the device can lead to
the generation of inaccurate diagnostic data. If inaccurate diagnostic
data are used in managing the patient, the physician may prescribe a
course of treatment that places the fetus and patient at risk
unnecessarily.
Adverse tissue reaction--Material in the device could
result in a systemic or local tissue reaction when the device comes in
contact with the patient.
Infection--If the device is not properly sterilized, it
may introduce microorganisms that could cause infection.
Fetal Scalp Clip Electrode and Applicator (Sec. 884.2685)
(1) Identification. A fetal scalp clip electrode and applicator is
a device designed to establish electrical contact between fetal skin
and an external monitoring device by means of pinching skin tissue with
a nonreusable clip. This device is used to obtain a fetal
electrocardiogram. This generic type of device may include a clip
electrode applicator.
(2) Summary of data. The Panel based its recommendation on personal
knowledge of, and experience with, the device. Information presented to
the Panel indicated a 1 to 2 percent infection rate for newborns on
whom fetal scalp clip electrodes were used (Ref. 41). The Panel noted
that this device is in limited use in the United States because the
circular (spiral) electrode, preferred because it is easier to apply
and remove, is available.
(3) Risks to health.
Adverse tissue reaction--Material in the device could
cause a local tissue or systemic reaction when the device comes in
contact with the fetus.
Infection--If the device is not properly sterilized, it
may introduce microorganisms that could cause infection.
Tissue damage--Poor design or incorrect application could
result in scalp injury when the device pinches the fetal scalp.
Expandable Cervical Dilator (Sec. 884.4250)
(1) Identification. An expandable cervical dilator is an instrument
with two handles and two opposing blades used manually to dilate
(stretch open) the cervix.
(2) Summary of data. The Panel based its recommendation on personal
knowledge of, and experience with, the device. The Panel members'
experience with the expandable cervical dilator had been that its
leverage is very difficult to control in such a way that the cervix is
dilated evenly.
(3) Risks to health.
Laceration of the cervix--Appropriate design and materials
are necessary to prevent trauma to the cervix and possible subsequent
infertility.
Adverse tissue reaction--Material in the device could
cause a local tissue or systematic reaction when the device comes in
contact with the patient.
Infection--If the device is not properly sterilized, it
may introduce microorganisms that could cause infection.
Vibratory Cervical Dilator (Sec. 884.4270)
(1) Identification. A vibratory cervical dilator is a device
designed to dilate the cervical os by stretching it with a power-driven
vibrating probe head. The device is used to gain access to the uterus
or to induce abortion, but is not to be used during labor when a viable
fetus is desired or anticipated.
(2) Summary of data. The Panel based its recommendation on
experience with, and personal knowledge of, the device. The Panel
reviewed the literature on the device and in a typical study of 50
patients, there were 3 failures to dilate and 3 patients with cervical
tears (Ref. 42). The Panel believed that more data concerning these
types of dilators were necessary before standards could be written.
(3) Risks to health.
Laceration of the cervix--Appropriate design and material
are necessary to prevent trauma to the cervix and possible subsequent
infertility.
Electrical shock--Malfunction of the device could result
in electrical shock to the patient.
Adverse tissue reaction--Material in the device could
cause a systemic or local tissue reaction when the device comes in
contact with the patient.
Infection--If the device is not properly sterilized, it
may introduce microorganisms that could cause infection.
[[Page 46725]]
Metreurynter-Balloon Abortion System (Sec. 884.5050)
(1) Identification. A metreurynter-balloon abortion system is a
device used to induce abortion. The device is inserted into the uterine
cavity, inflated, and slowly extracted. The extraction of the balloon
from the uterus causes dilation of the cervical os. This generic type
of device may include pressure sources and pressure controls.
(2) Summary of data. The Panel based its recommendation on the
Panel members' familiarity with the device and a review of the
literature on this device. Although journal articles discussing the use
of this device in Japan indicate that it may be safe and effective
(Refs. 43 and 44), the Panel believed that these data were inconclusive
and that more studies needed to be performed to establish the
performance characteristics of the device. A standard textbook
mentioned that the device is rarely used because of potential trauma or
infection, unpredictability, and the risk of a live-born fetus (Ref.
45).
(3) Risks to health.
Infection--If the device is not properly sterilized, it
may introduce microorganisms that could cause infection.
Trauma, laceration, hemorrhage, and perforation--Poor
design of the device could cause uneven dilation of the cervix causing
injury to the patient.
Adverse tissue reaction--Material or substances in the
device could cause a systemic or local tissue reaction when the device
comes in contact with the patient's cervix.
Unnecessary medical procedures--Loss of the device could
result in an otherwise unnecessary medical procedure to recover the
device from the uterus.
Abdominal Decompression Chamber (Sec. 884.5225)
(1) Identification. An abdominal decompression chamber is a
hoodlike device used to reduce pressure on the pregnant patient's
abdomen for the relief of abdominal pain during pregnancy or labor.
(2) Summary of data. The Panel based its recommendation on personal
knowledge of, and experience with, this device. The Panel considered
this device to be ineffective. Additionally, the Panel found no
literature available to supply adequate clinical data supporting any
claim of effectiveness. The consensus of the Panel was that any data
that might be developed would support an action to ban the device
because its risks outweigh its benefits.
(3) Risks to health.
Difficult patient management--The device is cumbersome and
covers the abdominal area of the patient, thus blocking the physician
from examining the patient.
Supine hypotension--Because the patient is required to lie
on her back, the possibility of induced low blood pressure and
consequent complications exists.
9. Orthopedic Devices
Ankle Joint Metal/Polymer Non-Constrained Cemented Prosthesis
(Sec. 888.3120)
(1) Identification. An ankle joint metal/polymer non-constrained
cemented prosthesis is a device intended to be implanted to replace an
ankle joint. The device limits minimally (less than normal anatomic
constraints) translation in one or more planes. It has no linkage
across-the-joint. This generic type of device includes prostheses that
have a tibial component made of alloys, such as cobalt-chromium-
molybdenum, and a talar component made of ultra-high molecular weight
polyethylene, and is limited to those prostheses intended for use with
bone cement (Sec. 888.3027).
(2) Summary of data. The members of the Orthopedic Devices
Classification Panel based their recommendation on the Panel members'
personal knowledge of the device and on the available medical
literature. According to Freeman (Ref. 47), ``It is still too early to
say whether this operation (total ankle joint replacement) offers any
advantages over arthrodesis * * *. It would appear a comfortable mobile
ankle can be produced but how reliably this can be done and how long
the results will last is impossible to say.'' The only available
clinical study on the device at the time of the Panel meeting had been
done by Newton (Ref. 48). From 1973 to 1978, 50 patients had this
prosthesis implanted. There have been 20 (40 percent) reported
failures. FDA believed these data are insufficient to establish the
safety and effectiveness of ankle joint metal/polymer non-constrained
prostheses.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Elbow Joint Humeral (Hemi-Elbow) Metallic Uncemented Prosthesis
(Sec. 888.3180)
(1) Identification. An elbow joint humeral (hemi-elbow) metallic
uncemented prosthesis is a device intended to be implanted, made of
alloys such as cobalt-chromium-molybdenum, that is used to replace the
distal end of the humerus formed by the trochlea humeri and the
capitulum humeri. The generic type of device is limited to prostheses
intended for use without bone cement (Sec. 888.3027).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device. The only available clinical data at the time of the Panel
meeting were the results of 2 surgeons who had implanted 18 devices
over a 10-year period (Ref. 49). An earlier publication (Ref. 50)
discussed the clinical results in what appeared to be the first 10 of
these 18 implantations. The devices had been implanted in nine patients
(one patient had prostheses implanted bilaterally). These patients were
evaluated 1 to 7 years later and only four patients (44 percent) had
stable, pain-free elbows with a functional range of motion. New bone
growth restricted or totally blocked elbow joint motion in three
patients. The device was removed in two other patients; because of
joint pain and swelling in one; and because the device had dislocated
and was eroding through the skin in the other.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in the loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and release of materials from the device to the
[[Page 46726]]
surrounding tissues and systemic circulation.
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Finger Joint Metal/Metal Constrained Uncemented Prosthesis
(Sec. 888.3200)
(1) Identification. A finger joint metal/metal constrained
uncemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal (MCP) or proximal interphalangeal (finger) joint.
The device prevents dislocation in more than one anatomic plane and
consists of two components which are linked together. This generic type
of device includes prostheses made of alloys, such as cobalt-chromium-
molybdenum, or protheses made from alloys and ultra-high molecular
weight polyethylene. This generic type of device is limited to
prostheses intended for use without bone cement (Sec. 888.3027).
(2) Summary of data. The only finger joint metal/metal constrained
uncemented prosthesis discussed in the literature at the time of the
Panel meeting was a two-pronged stainless steel hinged prostheses that
was developed by Flatt for use in the MCP and the proximal
interphalangeal (PIP) joints of the fingers.
Flatt presented clinical results with the Flatt finger prosthesis
in a series of publications over a 12-year period (Refs. 51 through
56). Thirty-one prostheses had been implanted for 6 months or more (6
months to 34 months); 23 in the PIP joint and 8 in the MCP joint. In
the earliest of these reports, Flatt noted that despite early
encouraging clinical results, the long-term outlook for the device did
not look favorable. In particular, Flatt noted that the bone absorption
that occurs around the neck of the prosthesis may possibly lead to
obstruction of flexion. Flatt also noted that possible complications
from use of the device might be: (a) Bone erosion in patients in whom
the intramedullary prongs have been forced together in the medullary
canal, and (b) metal fatigue and fracture of the intramedullary prongs.
Subsequent publications by Flatt (Refs. 55 and 56) showed that the
predicted complications did, in fact, occur. Flatt and Ellison (Ref.
55) reported on the implantation of 242 prostheses (167 in the MCP
joint and 75 in the PIP joint) with an average followup of 6.2 years
(range 1 to 12 years). Twenty-six (10.7 percent) of the prostheses (15
MCP and 11 PIP) had to be removed for the following reasons:
Periarticular fibrosis (bone resorption) and settling, 14; failure
(i.e., fracture) of both intramedullary prongs, 2; failure of the screw
holding the hinge together, 2; breakdown of the skin over the
prosthesis, 5; and infection, 3. The authors reported that of the
prostheses that required removal, more than half were removed because
of settling within the recipient bones. Bone absorption around the
intramedullary prongs, scarring, or heterotrophic bone formation around
the hinge caused sufficient mechanical difficulties to necessitate
removal of the prosthesis. Flatt and Ellison noted that the gradually
progressing periarticular fibrosis (bone resorption) resulted in a
decreased range of joint motion and was related to very active use of
the hand.
Girzados and Clayton (Ref. 57) reported on the implantation of 23
Flatt finger prostheses in 11 patients with an average followup of 44
months (range 24 to 73 months). Of the 23 prostheses implanted, 11 were
in the MCP joints of the fingers, 8 were in the PIP joints of the
thumb. Bone absorption around the neck and stems of the prosthesis
occurred in 16 of the 23 (69 percent) joints. Six prostheses (26
percent) were rated as poor results: Three had no motion
postoperatively; one was grossly unstable; and two were implanted in a
patient with active rheumatoid disease who, over a period of 64 months,
had intermittent swelling and pain over the joints that had been
replaced with the prostheses. The authors reported that ``good'' or
``fair'' results were obtained in 13 (56 percent) of the joints.
However, the number of patients having pain-free stable joints with a
useful range of motion (defined as ``good'') as opposed to those with
limited motion, minimal pain, and instability (defined as ``fair'')
could not be determined.
Problems associated with the Flatt finger prosthesis have been
recognized by many authors (Refs. 58 through 63). Several authors
(Refs. 58 and 59) reported that these prostheses have not been
generally accepted because of the accompanying bone resorption.
McFarland (Ref. 60) reported that the Flatt prosthesis had been only
moderately successful, that complications were frequent and included
bone overgrowth with loss of motion, migration of the prosthesis due to
bone erosion, and metal failures (i.e., device fractures). Goldner and
Urbaniak (Ref. 62) and Smith and Broudy (Ref. 63) noted that the bone
resorption and subsequent migration of the devices was caused by the
use of a rigid material in osteoporotic bone. Smith and Broudy (Ref.
63) also noted that the intramedullary prongs frequently migrate
through the cortex and occasionally the hinge would break or the
overlying skin would ulcerate, causing tendon rupture and infection.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation.
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Finger Joint Metal/Metal Constrained Cemented Prosthesis
(Sec. 888.3210)
(1) Identification. A finger joint metal/metal constrained cemented
prosthesis is a device intended to be implanted to replace a MCP
(finger) joint. This device prevents dislocation in more than one
anatomic plane and has components which are linked together. This
generic type of device include prosthesis that are made of alloys, such
as cobalt-chromium-molybdenum, and is limited to those prosthesis
intended for use with bone cement (Sec. 888.3027).
(2) Summary of data. Two types of these prostheses were discussed
in the literature: (a) The Link prostheses, a metallic hinge intended
to replace the MCP joint of a finger or thumb; and (b) the Biomedical
Laboratories of the University of Cincinnati (BLUC) prostheses, a
hinged metallic prostheses intended to replace the MCP joint of the
thumb.
Devas and Shah (Refs. 64 and 65) reported on the implementation of
51 Link prostheses in 25 patients with an average postoperative
followup of 4 years (range 2 to 6 years). In 15 (30 percent) of these
implantations, the patient had persistent pain in the joint and what
was described as a useless finger. The authors believed that the
proportion of patients with pain was far too large to make the
treatment method freely available. They noted that the main cause of
failure was due to loosening of the prostheses with disruption
(erosion) of the bone. They also noted that in most of the joints with
good and fair results the prosthesis had become loose but that the
patients were free from symptoms at the time of
[[Page 46727]]
evaluation. The authors believed that prosthesis loosening may have
been caused by fixation of the components by injecting the cement into
the metacarpal and phalangeal bone shafts, and it was noted that a
modified prosthesis with a different technique of insertion was being
considered (Ref. 65). Two papers (Refs. 66 and 67) described the design
and testing of the BLUC thumb prostheses. Clinical results, however,
were not presented. FDA believed that the data available on the
devices, the clinical results of the use of the devices in 25 patients
with a reported failure rate of 30 percent, and the recommendation by
the authors that the procedure not be made freely available, did not
establish the long-term safety and effectiveness of finger joint metal/
metal constrained prostheses.
(3) Risks to health
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation.
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Finger Joint Metal/Polymer Constrained Cemented Prosthesis
(Sec. 888.3220)
(1) Identification. A finger joint metal/polymer constrained
cemented prosthesis is a device intended to be implanted to replace a
MCP or proximal interphalangeal (finger) joint. The device prevents
dislocation in more than one anatomic plane, and consists of two
components which are linked together. This generic type of device
includes prostheses that are made of alloys, such as cobalt-chromium-
molybdenum, and ultra-high molecular weight polyethylene, and is
limited to those prostheses intended for use with bone cement
(Sec. 888.3027).
(2) Summary of data. Clinical results on three designs of finger
joint polymer constrained prostheses were presented in the literature:
The Calnan-Nicolle prosthesis, intended for use in the MCP and PIP
joints for the fingers; the Niebauer prosthesis also intended for use
in the MCP and PIP joints of the fingers; and the Swanson prosthesis
intended for use in the MCP and PIP joints of the fingers and for the
MCP joint of the thumb.
a. Calnan-Nicolle prosthesis. This device has two components: An
across-the-joint component having intramedullary stems and a flexible
hinge made of polypropylene, and a silicone rubber sleeve which
encapsulates the flexible hinge portion of the device (Ref. 72).
Griffiths and Nicolle (Ref. 73) reported on the clinical results 8 to
37 months (average of 20 months) after implantation of the Calnan-
Nicolle device in 112 MCP joints in 31 patients. Complete relief from
pain was obtained in four (13 percent) patients. There was much
improvement over preoperative pain status in 13 (42 percent), moderate
pain relief in 10 (32 percent), and little pain relief in 4 (13
percent) patients. These authors reported that a deterioration in the
performance of the prosthesis occurred in up to half of the patients
between 1 and 2 years after insertion of the prosthesis; and that part
of the deterioration in function was due directly to mechanical failure
of the prosthesis. The range of joint motion had deteriorated over time
in 33 of the 40 (82.5 percent) hands on which surgery was performed.
Joint deformity was ``corrected and held'' in 10 to 31 hands (32
percent), was corrected initially but recurred in 14 of 31 (45 percent)
hands, and worsened in 7 of 31 (23 percent) hands. The silicone capsule
(sleeve) had fractured in 31 of the 112 prostheses (28 percent). The
polypropylene stems had fractured in five joints (5 percent). Nicolle
(Ref. 71) noted that time and experience had shown that the
polypropylene hinge of the Calnan-Nicolle prosthesis does not appear to
be strong enough to withstand fully the compression and torsional
stresses that may occur in the use of the hand.
b. Niebauer prosthesis. This device consists of a single, flexible,
across-the-joint component. The intramedullary stems and the flexible
hinge portion of the device are made of silicone to allow tissue
penetration and fixation of the stems. Beckenbaugh et al. (Ref. 75)
reported on the clinical results 12 to 65 months (average 32 months)
after implantation in the MCP joints of 68 Niebauer prostheses and
found a fracture rate of the device of 38.2 percent (26 devices),
recurrence of clinical deformity in 44.1 percent (30 devices) and
recurrence of pain in 2 percent. Goldner et al. (Ref. 76) reported a
fracture rate of 29.7 percent in 37 prostheses implanted for 6.5 years
and 17.5 percent fracture rate in 143 prostheses implanted 4 to 6
years. These authors believe that the silicone-polyester material used
in the device may absorb lipids and become brittle, and that eventual
fracture of the prosthesis is a possibility, but that fracture does not
preclude a good functional result. Goldner and Urbaniak (Ref. 77)
evaluated 103 patients over a 4-year period. Pain was relieved or
greatly diminished postoperatively in all but 8 of the 103 patients.
The average active range of motion in these patients was 51 degrees.
The range of motion was noted to increase up to about 1 year
postoperatively; and then thought to decrease slightly, possibly due to
enlarged bony outgrowths from the surface of the bone and impingement
of peripheral bone on the hinge of the device. In two (2 percent) of
patients, the device had fractured, which was accompanied by deformity
and a moderate amount of pain.
Hagert (Ref. 78) conducted X-ray examinations on 41 joints with
Niebauer implants. This author reported that of the 41 prostheses
studied, 26 (63.4 percent) were found to be damaged (i.e., cracked
within the implant midsection, fragmented at the midsection, or
fractured at the hinge), 1 to 36 months postoperatively. This author
believed that the Niebauer implant might be too weak to withstand
forces in the MCP joints, and that a possible contributing factor was
the use of materials (polyester fiber and silicone rubber) with
differing elasticity. This author noted that the Niebauer implant was
reported to have withstood 100 million flexions during mechanical tests
bending it around a fixed axis, but not exposing it simultaneously to
shearing type forces which are present in the MCP joint. These shearing
forces were reportedly most probably responsible for the deformation of
the implant and the subsequent damage observed. Niebauer and Landry
(Ref. 79) reported that destruction of the bone around the hinge of the
device had occurred in a few cases and that this atrophy may be the
result of pressure from the prosthesis. In an evaluation by X-ray of
the 41 Niebauer prostheses, Hagert (Ref. 78) observed bone resorption
in 23 of the 41 joints (56 percent). The cortex of the bone was
penetrated in 13 (32 percent) of these joints. It was reported that the
observed erosion of the bone is most likely caused by motion of the
intramedullary stems within the medullary cavity, and is exaggerated by
the rough polyester surface of the device.
c. Swanson prosthesis. This device is made entirely of silicone
rubber and is
[[Page 46728]]
designed to act as an internal mold, maintaining joint alignment,
becoming encapsulated and stabilized by fibrous tissue, and gliding or
moving within the medullary cavity rather than being fixed to the bone
(Ref. 80). A number of reports (Refs. 75 and 80 through 86) were found
describing the use of the Swanson prostheses in the MCP joints of the
fingers, but few reports (Refs. 87 through 90) were available
describing the use of this device in the MCP joint of the thumb, or the
PIP joints of the fingers. In 1976, it was reported that a new ``high
performance'' silicone elastomer material had been developed for use in
the Swanson prosthesis. With the exception of one report (Ref. 90), the
available clinical data were obtained using prostheses made from the
``conventional'' silicone elastomer. Fracture of implants made of the
``conventional'' silicone elastomer appears to be the most frequently
reported failure. Beckenbaugh et al. (Ref. 75) reported that of 186
Swanson prostheses implanted in the MCP joint for an average of 32
months (range 12 months to 65 months), 26.3 percent (49) had fractured.
Hagert et al. (Ref. 82) reported that of 104 Swanson implants
evaluated, 25 percent (26) had failed, either by cracking or
fragmenting and fracturing within the followup period of 1.5 to 5
years. Mannerfelt and Anderson (Ref. 83) reported a fracture rate of
2.8 percent in 144 joints evaluated 1.5 to 3.5 years (average 2.5
years) after implantation. Ferlic et al. (Ref. 84) reported a fracture
rate of 9 months (average 2.3 years) after implantation. Swanson (Ref.
80) reported the lowest rate of fracture, 0.88 percent, in a field
clinic series involving over 3,000 implants with a followup of from 6
to 30 months.
The effects of fracture of the device on the clinical results were
evaluated by several authors. Aptekar et al. (Ref. 85) described the
occurrence of detritic synovitis (inflammation of the synovial tissue)
due to shards of silicone rubber found in relation to a broken
prosthesis. Beckenbaugh et al. (Ref. 75) noted that recurrence of
deformity was associated with implant fracture, i.e., ulnar drift, in
14 percent; weakness or instability in 21 percent; hyperextension in 11
percent; and some clinical deformities in 43 percent; but that while
the recurrence of deformity implied that soft tissue balance was not
present after the implant fractured, it was not clear whether the
imbalance caused the fracture or developed because of it.
Hagert (Ref. 86) believed that the increased displacement, i.e.,
ulnar deviation, noted in some joints with fractured implants, may
indicate insufficiency of the fibrous capsule surrounding the implant
to restrain the forces occurring at the MCP joint. This pressure,
combined with movement of the implant within the medullary canal was
reportedly found to cause a moderately progressive bone resorption
throughout the followup period in all of the 36 joints examined.
Resorption was observed around the midsection of the prosthesis where
the implant was in close contact with bone and around the
intramedullary stems of the device. Erosion of bone around the
midsection of the device led to various degrees of migration of the
device in 28 out of 36 (78 percent) of the joints examined. The author
found that decreased joint flexion was observed due either to the
distal migration of the implant or a growing volar bony spur in 13 out
of the 39 (33 percent) joints examined. He concluded that the design of
the device may be insufficient to fully restrain the volarly and
proximally directed forces in the MCP joint and the serious decrease of
flexion. Hagert et al. (Ref. 82) reported that although it is generally
accepted that silicone rubber absorbs lipids and other substances, the
effects on material changes and degradation is not adequately known.
Weightman et al. (Ref. 87) noted that lipid absorption could contribute
to mechanical failure of the prostheses, as chemical deterioration is
known to be a prime initiator of fatigue failures of polymers. Other
clinical results have been reported in the literature (Refs. 80, 81,
87, and 89) on the use of this prosthesis in large numbers of patients.
These results were very similar to those summarized previously.
(3) Risks to health.
Loss or reduction of joint function--Improper design of
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Hip Joint Metal Constrained Cemented or Uncemented Prosthesis
(Sec. 888.3300)
(1) Identification. A hip joint metal constrained cemented or
uncemented prosthesis is a device intended to be implanted to replace a
hip joint. The device prevents dislocation in more than one anatomic
plane and has components that are linked together. This generic type of
device includes prostheses that have components made of alloys, such as
cobalt-chromium-molybdenum, and is intended for use with or without
bone cement (Sec. 888.3027). This device is not intended for biological
fixation.
(2) Summary of data. The agency has obtained data and information
describing the use of hip joint metal constrained prostheses. Sivash
(Ref. 91) reported on implantation in 164 patients; followup time was 1
to 9 years. Breakage of the prosthesis was reported in 13 (8 percent)
of the patients. Because of the lack of adequate data to demonstrate
the safety and effectiveness of these implanted devices, FDA believed
that use of the hip joint metal constrained prosthesis presents an
unreasonable risk of illness or injury.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device, or loosening of the device in the
surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to a dissolution or wearing away from the surfaces
of the device and the release of material from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis
(Sec. 888.3310)
(1) Identification. A hip joint metal/polymer constrained cemented
or uncemented prosthesis is a device intended to be implanted to
replace a hip joint. The device prevents dislocation in more than one
anatomic plane and has components that are linked together. This
generic type of device includes prostheses that have a femoral
component made of alloys, such
[[Page 46729]]
as cobalt-chromium-molybdenum, and an acetabular component made of
ultra-high molecular weight polyethylene. This generic type of device
is intended for use with or without bone cement (Sec. 888.3027). This
device is not intended for biological fixation.
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation.
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Hip Joint (Hemi-Hip) Acetabular Metal Cemented Prosthesis
(Sec. 888.3370)
(1) Identification. A hip joint (hemi-hip) acetabular metal
cemented prosthesis is a device intended to be implanted to replace a
portion of the hip joint. This generic type of device includes
prostheses that have an acetabular component made of alloys, such as
cobalt-chromium-molybdenum. This generic type of device is limited to
those prostheses intended for use with bone cement (Sec. 888.3027).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Hip Joint Femoral (Hemi-Hip) Trunnion-Bearing Metal/Polyacetal Cemented
Prosthesis (Sec. 888.3380)
(1) Identification. A hip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis is a two-part device intended to
be implanted to replace the head and neck of the femur. This generic
type of device includes prostheses that consist of a metallic stem made
of alloys, such as cobalt-chromium-molybdenum, with an integrated
cylindrical trunnion bearing at the upper end of the stem that fits
into a recess in the head of the device. The head of the device is made
of polyacetal (polyoxymethylene) and it is covered by a metallic alloy,
such as cobalt-chromium-molybdenum. The trunnion bearing allows the
head of the device to rotate on its stem. The prosthesis is intended
for use with bone cement (Sec. 888.3027).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device and on a presentation to the Panel. Dr. Ian Goldie (University
of Goteborg) presented the results of several Norwegian studies with
these prostheses. Dr. Goldie referred to Christiansen's series of 241
hips in which excellent results were obtained in 57 percent of the
cases and good results in 33 percent. In this series, there were five
infections, seven cases of loosening of the acetabular cup, two
dislocations shortly after operation, two cases of femoral perforation,
and three cases of heterotopic ossification. Dr. Goldie then presented
the results of his own series of 61 patients. In the 19 patients with 2
years followup, and in the 28 patients with 6 months followup, there
were no complications. However, in the remaining 14 patients with a
followup of 1 year, there were the following complications: 2
dislocations between the head and the cup, 2 cases of heterotopic
ossification, and 2 patients with inexplicable pain.
FDA sought additional data and information on the safety and
effectiveness of these devices. A review of the medical literature
revealed a disagreement regarding the resistance to wear of polyacetal
materials. McKellop et al. (Ref. 92) reported that laboratory wear
rates for polyacetal ranged from 70 percent lower than polyethylene to
540 percent higher. Dumbleton (Ref. 93) reported wear in the trunnion
sleeve of the device and that polyacetal exhibits a low resistance to
wear. Because of the potential problems involving its resistance to
wear, the long-term effectiveness of this device is questionable. The
initial investigator and his associates have been the primary users of
this device. Long-term followup data are available only from the
initial investigator. Clinical cases documenting effectiveness and
safety of the device involve usage of less than 3 years.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction in
joint function due to excessive wear, fracture, deformation of the
device components, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility or resistance to wear, may result in an adverse tissue
reaction due to dissolution or wearing away of the surfaces of the
device and the release of materials from the device to the surrounding
tissues and systemic circulation. -
Infection--The presence of a prosthesis within the body
may lead to an increased risk of infection.
Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis
(Sec. 888.3480)
(1) Identification. A knee joint femorotibial metallic constrained
cemented prosthesis is a device intended to be implanted to replace
part of a knee joint. The device prevents dislocation in more than one
anatomic plane and has components that are linked together. The only
knee joint movement allowed by the device is in the sagittal plane.
This generic type of device includes prostheses that have an
intramedullary stem at both the proximal and distal locations. The
upper and lower components may be joined either by a solid bolt or pin,
an internally threaded bolt with locking screw, or a bolt retained by
circlip. The components of the device are made of alloys, such as
cobalt-chromium-molybdenum. The stems of the device may be perforated,
but are intended to be implanted with a polymethylmethacrylate luting
agent (bone cement).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and experience with, the device,
and its
[[Page 46730]]
review of the medical literature. Results from using the device in more
than 720 cases have been reported in the medical literature in the
United States during the past 3 years (Refs. 94, 100, and 103). Reports
in the medical literature exist that document use of the device in
several thousand cases worldwide during the past 10 years. The Panel
believed that this extensive clinical use has revealed the usual
mechanical problems, implant loosening and settling. The Panel
determined that the overall risks resulting from use of the prosthesis
were no worse than the risks associated with major knee surgery without
implantation of a prosthesis.
Of the 957 patients reviewed by the Panel who have had this
prosthesis implanted and who were discussed in the worldwide medical
literature (Refs. 94 through 105), 108 (11 percent) suffered implant
failure, 233 (24 percent) of the cases had complications, and 104 (11
percent) had loosening of the prosthesis.
FDA sought additional data on the safety and effectiveness of this
device. Kettelkamp (Ref. 105) reported that the failure rate for the
device ranges from 5 percent to 24 percent for the hinged metal knee
prosthesis, with a short followup time. Kettlekamp (Ref. 105) and Chand
(Ref. 106) both believe that excessive forces may be applied to the
intramedullary stem bone cement interface because the constrained
prosthesis hinge prevents medial/lateral joint movement. Kettlekamp
believes that if the stem loosens, the cement may rub away and destroy
the surrounding bone, causing a larger cavity and making revision
difficult or impossible.
Kettlekamp reviewed reports in the medical literature on use of 576
Walldius hinged knee prostheses. In one group of 144 implantations,
complications occurred in 29 cases (13 percent). In the remaining 432
cases, 89 (20 percent) were classified as failures, 33 (7 percent)
required reoperations, and 53 (12 percent) had loosening. Fractures
occurred in 11 cases (2 percent) and deep infection was reported in 35
knees (8 percent). Kettlekamp reported that the incidence of
complication increased with the length of reported followup. Brady and
Garber (Ref. 103) reviewed results of implanting the Shiers design of
this device in 288 knees. He reported poor results in 71 knees (24
percent), reoperation was required in 33 knees (11 percent), and
loosening observed in 56 knees (19 percent). Brady stated that the
major problems involved with use of these prosthesis are the absence of
axial (medial) rotation, the necessary resection of large amounts of
bone, and the creation of physiologic dead space.
Kettlekamp (Ref. 105) and Deburge et al. (Ref. 107) reported that
the major problem with the Shiers design prosthesis is loosening.
Deburge reported a loosening rate of 15 percent (22 patients) during a
5-year followup of the request of implanting the Guepar constrained
knee prosthesis in 152 patients. However, less than half of these
instances of device loosening were symptomatic (10 of 22 patients).
Reoperations were performed on the 10 patients. Other authors (Ref.
100) believed that the rate of loosening of the prosthesis is higher,
possibly around 80 percent, but that only a small percentage of those
patients with device loosening are symptomatic.
Arden and Kamdar (Ref. 108) reported followup for 7 years on
implantation of 193 Shiers design prostheses. They reported that 11
percent of the patients had aseptic loosening. Kaushal et al. (Ref.
109) reported followup examination of a series of 30 knees about 42
months following implantation of the prosthesis. The examination
revealed that 13 knees (46 percent) had phlebothrombosis, 8 knees (11
percent) had asymptomatic loosening, 4 knees (5.4 percent) had deep
infections, and 3 knees (4.3 percent) had symptomatic loosening. The
major problems with use of the prosthesis were settling, loosening, and
limitation on the range of joint motion allowed. In preliminary data,
Van Camp et al. (Ref. 110) showed that stress loading appeared to cause
mechanical loosening of the device.
Walker (Ref. 111) stated that the valgus angle of the knee was
ignored in the older designs of this prosthesis. Walker said this
design problem resulted in lateral stress on the intramedullary stems
of the device. This theory was verified experimentally by Wagner and
Bourgois (Ref. 112). Wagner and Bourgois also showed that, in both the
Walldius and Shiers designs of the prosthesis, the prosthesis' axis of
rotation was not equivalent to the axis of the anatomic joint it
replaced. These researchers said the pin in the Shiers prosthesis was
turned down on the axis and that it might loosen if the prosthesis were
overstressed. Because the axle pin of the Walldius prosthesis is
clamped on one side, the location of the axis causes localized wear.
Although infection immediately following implantation of a
prosthesis is primarily a result of surgical technique, Swanson et al.
(Ref. 113) stated that the design of the prosthesis may minimize the
rate of infection associated with implantation. Swanson found that the
infection rate was lower when less bone was removed for insertion of
the device. Phillips and Taylor (Ref. 98) reported that most groups of
patients who have received this prosthesis have suffered about a 10
percent higher incidence of infection than patients in whom other
generic types of knee prostheses have been implanted.
In cases of total failure of implantation of a joint prosthesis,
the prosthesis may be removed and the joint fused (arthrodesis). The
rate of success in performing arthrodesis is related to the amount of
bone that was removed to implant the device. Arthrodesis is difficult
following implantation of a constrained joint replacement device.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented
Prothesis (Sec. 888.3540)
(1) Identification. A knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis is a two-part device intended to be
implanted to replace part of a knee joint in the treatment of primary
patellofemoral arthritis or chondromalacia. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surfaces. It has no linkage across-the-joint. This generic
type of device includes a component made of alloys, such as cobalt-
chromium-molybdenum or austenitic steel, for resurfacing the
intercondylar groove (femoral sulcus) on the anterior aspect of the
distal femur, and a patellar component made of ultra-high molecular
weight polyethylene. This generic type of device is limited to those
devices intended for use with bone cement (Sec. 888.3027). The patellar
component is designed to be implanted only with its femoral component.
[[Page 46731]]
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of, and experience with, similar
devices and a presentation made to the Panel. Fox reported on his
clinical experience with this generic type of device. Fox stated that
patellofemoral joint replacement was performed in more than 60 knees,
with the followup since 1974. He reported that he, as well as his
patients, were pleased with the results.
Other than the presentation to the Panel made by Fox, FDA was not
aware of any clinical data for this device. Moreover, because Fox
provided no details regarding the device or its implantation procedure,
FDA was not certain that the devices Fox implanted belong to this
generic class.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution of wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Knee Joint Patellofemorotibial Polymer/Metal/Metal Constrained Cemented
Prosthesis (Sec. 888.3550)
(1) Identification. A knee joint patellofemorotibial polymer/metal/
metal constrained cemented prosthesis is a device intended to be
implanted to replace a knee joint. The device prevents dislocation in
more than one anatomic plane and has components that are linked
together. This generic type of device includes prostheses that have a
femoral component, a tibial component, a cylindrical bolt and
accompanying locking hardware that are all made of alloys, such as
cobalt-chromium-molybdenum, and a retropatellar resurfacing component
made of ultra-high molecular weight polyethylene. The retropatellar
surfacing component may be attached to the resected patella either with
a metallic screw or luting agent. All stemmed metallic components
within this generic class are intended to be implanted with a
polymethylmethacrylate luting agent (bone cement).
(2) Summary of data. The Panel based its recommendation on the
Panel members' knowledge of, and experience with, the device and a
presentation made to the Panel. Pritchard and Fox described their
experiences with various patellofemoral joint replacing devices
including this generic type of device. Pritchard has implanted
patellofemorotibial joint prostheses in at least 100 patients during
the 3 years prior to the Panel meeting. Also, Fox reported that he has
achieved good results in over 60 cases since 1974. In May 1962, Young
(Ref. 116) reported on a series of 16 patients ranging in age from 31
to 70 years who had a Young design prosthesis implanted (2 were
bilateral implantations). With a followup time between 9 and 61 months
(median of 20 months), 7 of these 16 experienced a clinical failure
(43.8 percent) with a mean time of about 9 months before prosthesis
removal and arthrodesis (joint fusion). In a later report in 1971,
Young (Ref. 120) stratified results by indication: At least 3 of 19
osteoarthritic knees were failures (15.8 percent incidence); at least
17 of 45 rheumatoid knees failed (37.8 percent incidence); of 4
replacements for giant-cell tumor, 2 failed (50 percent incidence); and
at least 6 of 10 traumatic arthritic knees failed (60 percent
incidence).
Young noted that nine knees examined sometime after initial
implantation demonstrated darkening in tissue adjacent to metallic
components. Young believed that the darkening of tissue was caused by
tissue contamination from corrosion products. Young also believed that
similar tissue darkening was noted by Girzadas et al. (Ref. 117). Young
believed that the darkening was caused by the bolts used in his design
that were made from a cobalt-based alloy, whereas the other components
were made from a casting alloy. Young stated that, as a result of his
survey of the clinical results for 85 physicians who had implanted the
Young-design prosthesis, he was not optimistic about use of the hinged
metal/metal knee prostheses and their future for replacement
arthroplasty.
In 1973, Hanslik (Ref. 121) reported results of using the device in
50 patients (two bilaterally implanted), principally for the indication
of stereoarthrosis. Minimum followup was not given, while maximum
followup was possibly 4 years. The patients ranged in age from 56 to 76
years. At least four failures (8 percent) were associated with
restricted gliding of the patellofemoral articulation: One of these was
attributed to polymethylmethacrylate-induced bony necrosis. Hanslik
used the Young (Ref. 116) design of prosthesis and had made major
modifications in implantation technique as recommended by Friedebold
and Radloff (Refs. 115, 118, and 120). Hanslik performed partial
resection of the patella rather than total excision and used a
polymethylmethacrylate luting agent to grout the medullary stems
(presumably in addition to the cancellous bone screws recommended by
Young). Friedebold and Radloff (Ref. 119) reported on use of the
prosthesis in femorotibial replacement in 11 patients ranging in age
from 50 to 80 years, with between 6 months and 5 years of followup.
There were three failures (27.3 percent).
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reactions--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surface of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Knee Joint Femoral (Hemi-Knee) Metallic Uncemented Prosthesis
(Sec. 888.3570)
(1) Identification. A knee joint femoral (hemi-knee) metallic
uncemented prosthesis is a device made of alloys, such as cobalt-
chromium-molybdenum, intended to be implanted to replace part of a knee
joint. The device limits translation and rotation in one or more planes
via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generic type of device includes prostheses that
consist of a femoral component with or without protuberance(s) for the
enhancement of fixation and is limited to those prostheses intended for
use without bone cement (Sec. 888.3027).
(2) Summary of data. FDA was concerned about both the severity of
the clinical complications resulting from use of the device and the
rate at which these complications occur. The agency
[[Page 46732]]
used the complication classification scheme developed by Fox (Ref. 122)
and grouped complications by time periods following surgical
implantation; immediate postoperative complications, within 2 weeks;
short term, within 24 months; and long term, more than 24 months. Platt
and Pepler reported in 1969 their clinical results on 55 patients who
had this prosthesis implanted with up to 10 years followup (Ref. 123).
Their reported incidence of complications ranged from: General--none
reported; systemic--none reported; and remote--1 late (2 years
postoperatively) paranoid schizophrenia (1.8 percent); and (4) local--
at least 45 percent. The most frequent complication was immediate
postoperative infection with a presumed incidence of 25.5 percent. The
reoperation rate for this series of patients was reported as 20 out of
62 knees or 32.4 percent; assuming only 1 reoperation per patient, a
36.4 percent revision rate will result.
Aufranc and Jones et al. (Refs. 124 and 125) made extensive
modifications to M. Smith-Peterson's original ``keeled'' femoral
condylar mold (Ref. 126) and commenced a series of device implantations
employing a noncemented stemmed implant in 1952. Clinical results on 64
patients with a minimum of 1-year followup showed that the incidence of
complications were: Zero for general and remote categories; 3.1 percent
for systemic (2 thrombophlebitic episodes); and a minimum of 25 percent
for cumulated local complications. Matching Platt and Pepler's
experience (Ref. 124), the most frequent complication observed was
immediate postoperative infection with a presumed incidence of 20.3
percent. This series of patients, as of mid-1969, displayed a
reoperation rate of 14 out of 79 knees (17.7 percent), assuming only 1
reoperation per patient. Considering this result, with their report of
16 clinical results rated at less than ``fair,'' the failure rate is
calculated as 38 percent with an average followup time of 87 months.
Aufranc and Jones (Ref. 124) noted that 6 of their initial 14
implantations were failures (42.9 percent) with a maximum followup of 5
years; apparently 10 more years of surgical experience reduced the
overall failure rate by 5 percent, without altering the principal
reported failure modes: Infection and ``poor'' clinical result.
Further review of available literature (Refs. 108 and 127 through
136), failed to disclose device experience that would significantly
alter the trends described above.
(3) Risks to health.
Loss or reduction of joint or limb function--Improper
design or inadequate mechanical properties of the device, such as its
lack of strength and resistance to wear, may result in the loss or
reduction of joint function due to excessive wear, fracture,
deformation of the device, or loosening of the device in the surgical
cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution of wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and the systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Death--Death may result from lipoembolic sequelae or
thromboembolic complications during or immediately following
implantation.
Knee Joint Patellar (Hemi-Knee) Metallic Resurfacing Uncemented
Prosthesis (Sec. 888.3580)
(1) Identification. A knee joint patellar (hemi-knee) metallic
resurfacing uncemented prosthesis is a device made of alloys, such as
cobalt-chromium-molybdenum, intended to be implanted to replace the
retropatellar articular surface of the patellofemoral joint. The device
limits minimally (less than normal anatomic constraints) translation in
one or more planes. It has no linkage across-the-joint. This generic
type of device includes prostheses that have a retropatellar
resurfacing component and an orthopedic screw to transfix the patellar
remnant. This generic type of device is limited to those prostheses
intended for use without bone cement (Sec. 888.3027). This device is in
class III when intended for uses other than treatment of degenerative
and posttraumatic patellar arthritis; when intended for those uses, it
is in class II.
(2) Summary of data. FDA was not aware of any valid scientific
evidence supporting the safety and effectiveness of this device when
intended for uses other than the treatment of degenerative and
posttraumatic patellar arthritis.
3. Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Shoulder Joint Metal/Metal or Metal/Polymer Constrained Cemented
Prosthesis (Sec. 888.3640)
(1) Identification. A shoulder joint metal/metal or metal/polymer
constrained cemented prosthesis is a device intended to be implanted to
replace a shoulder joint. The device prevents dislocation in more than
one anatomic plane and has components that are linked together. This
generic type of device includes prostheses that have a humeral
component made of alloys, such as cobalt-chromium-molybdenum, and a
glenoid component made of this alloy or a combination of this alloy and
ultra-high molecular weight polyethylene. This generic type of device
is limited to those prostheses intended for use with bone cement
(Sec. 888.3027).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of the device and on their knowledge
of the medical literature (Refs. 136 through 139). Two of these
references (Refs. 136 and 137) described a shoulder joint constrained
prosthesis (Fenlin and Zippel designs) and report that implantation of
the device relieved pain in 16 of 17 patients. In the patient with the
painful prosthesis, the authors believed that the device had loosen.
The times of implantation were not reported.
Fenlin (Ref. 138) reported that the Fenlin design prosthesis had
been implanted in five patients. The results in three of these patients
were discussed. One patient was described as being free of pain, and
able to use the operated shoulder for all normal activities, except
those requiring elevation of the arm above 80 deg.. The length of
followup in this patient was 20 months. Complications were reported in
the other two patients. In one patient, the device had loosened at 3
months postoperatively, due to abnormal anatomy of the glenoid. The
second patient suffered partial nerve palsy due to damage of the
axillary nerve during surgery. Linscheid and Cofield (Ref. 139)
reported on the implantation of 13 constrained shoulder joint
prostheses (6
[[Page 46733]]
of the Stanmore design, and 7 of the Bickel design). The average time
of followup was reported as 13 months and ranged from 2 to 26 months.
There were two cases of dislocations of the Stanmore design prosthesis
and one case of dislocation of the Bickel design prosthesis. There were
two additional complications reported with the Bickel design device;
one case of fracture of the humeral component and one case of loosening
of the glenoid component.
FDA sought additional information on the safety and effectiveness
of these devices. Cofield (Ref. 140) reported that prosthetic
replacement of the shoulder joint was in 1971, an experimental,
investigational procedure. This author noted that basic knowledge about
shoulder biomechanics was limited and that current knowledge of
shoulder prostheses was not sufficient to establish the requirements of
a prosthetic replacement. Buechel et al. (Ref. 141) noted that
complications with current shoulder prostheses have been associated
with the designs of the devices: (1) The Bickel design shoulder joint
prosthesis was reported to dislocate and loosen due to the limited
motion of the prosthesis; and (2) the prosthesis design used by Lettin
and Scales (presumably the Stanmore design shoulder prosthesis) was
reported to significantly limit joint motion, then sublux, and
eventually dislocate at the extremes of normal joint motion. Clinical
results with several prosthesis designs were reported by Cofield (Ref.
140, 142, and 143). Eleven persons in whom Bickel design prostheses had
been implanted were evaluated 18 months to 39 months postoperatively
(Ref. 142). Three (27 percent) were experiencing significant pain. The
components of the Bickel device had dislocated in two cases. The
glenoid component had dislodged from the scapula in two cases and
loosened in one. The humeral component had fractured in two other
cases. Reoperation was required in four patients and was needed in two
or three others. Cofield reported that further clinical and mechanical
deterioration in these patients was anticipated due to progressive
loosening of the glenoid components and fatigue fracture of the neck of
the humeral component, which was not believed to be strong enough.
These authors concluded that this type of shoulder joint replacement
(i.e., the Bickel design) is not justified. Cofield (Refs. 140 and 143)
also reported clinical results in nine patients who had received
Stanmore prostheses. After an average postoperative time of 1 year
(ranging between 4 and 18 months), six patients had satisfactory relief
of pain and three had significant pain. The glenoid component had
loosened in two patients. FDA concurred with the Panel that the
reported clinical experience with these devices did not establish their
long-term safety and effectiveness.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. - -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Shoulder Joint Glenoid (Hemi-Shoulder) Metallic Cemented
(Sec. 888.3680) Prosthesis
(1) Identification. A shoulder joint glenoid (hemi-shoulder)
metallic cemented prosthesis is a device that has a glenoid (socket)
component made of alloys, such as cobalt-chromium-molybdenum, or alloys
with ultra-high molecular weight polyethylene and intended to be
implanted to replace part of a shoulder joint. This generic type of
device is limited to those prostheses intended for use with bone cement
(Sec. 888.3027).
(2) Summary of the data. The Panel based its recommendation on the
Panel members' personal knowledge of, and clinical experience with, the
device.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and the release of materials from the device to the
surrounding tissues and systemic circulation. -
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
Wrist Joint Metal Constrained Cemented Prosthesis (Sec. 888.3790)
(1) Identification. A wrist joint metal constrained cemented
prosthesis is a device intended to be implanted to replace a wrist
joint. The device prevents dislocation in more than one anatomic plane
and consists of either a single flexible across-the-joint component or
two components linked together. This generic type of device is limited
to a device which is made of alloys, such as cobalt-chromium-
molybdenum, and is limited to those prostheses intended for use with
bone cement (Sec. 888.3027).
(2) Summary of data. The Panel based its recommendation on the
Panel members' personal knowledge of the device and on the available
medical literature. Gschwend et al. (Ref. 144) used this prosthesis in
15 cases from 1971 through 1975. Fixation was reported to be inadequate
and not correlated to loads imposed on the wrist joint. In three cases
(20 percent), the distal stem became loose. The stem fractured in two
cases (13 percent). On one occasion (6.6 percent) the metacarpal bone
broke. In another case, as a result of a disturbance of muscle balance,
the investigators observed a fixed ulnar deviation of the wrist joint
with a tendency toward radial penetration of the medullary canal of the
third metacarpal bone. The investigators also described three cases (20
percent) of a sinking of the prosthesis into the capitate through the
third metacarpal.
(3) Risks to health.
Loss or reduction of joint function--Improper design or
inadequate mechanical properties of the device, such as its lack of
strength and resistance to wear, may result in a loss or reduction of
joint function due to excessive wear, fracture, deformation of the
device, or loosening of the device in the surgical cavity.
Adverse tissue reaction--Inadequate biological or
mechanical properties of the device, such as its lack of
biocompatibility and resistance to wear, may result in an adverse
tissue reaction due to dissolution or wearing away from the surfaces of
the device and release of materials from the device to the surrounding
tissues and systemic circulation.
Infection--The presence of the prosthesis within the body
may lead to an increased risk of infection.
[[Page 46734]]
10. Physical Medicine Devices
Rigid Pneumatic Structure Orthosis (Sec. 890.3610)
(1) Identification. A rigid pneumatic structure orthosis is a
device intended for medical purposes to provide whole body support by
means of a pressurized suit to help thoracic paraplegics walk.
(2) Summary of data. The Panel based its recommendation on the
literature concerning the device (Refs. 145 and 146). The literature
evaluation did not demonstrate that the device was safe or effective
(Ref. 146). The rigid pneumatic structure orthosis was also evaluated
as requested by the Veterans' Administration and the Rehabilitation
Services Administration, Department of Health, Education, and Welfare
(Ref. 146), and did not meet adequate performance standards for safety
and effectiveness.
(3) Risks to health.
Bodily injury--The device could collapse and the patient
could fall, resulting in bodily injury, if inflation is lost or the
zippers fail.
Tissue trauma and/or pressure sores--Tissue trauma and/or
pressure sores could result if the support beams overinflate and cause
excessive pressure on the skin of the patient.
II. PMA Requirements
A PMA for these devices must include the information required by
section 515(c)(1) of the act. Such a PMA should also include a detailed
discussion of the risks identified above, as well as a discussion of
the effectiveness of the device for which premarket approval is sought.
In addition, a PMA must include all data and information on: (1) Any
risks known, or that should be reasonably known, to the applicant that
have not been identified in this document; (2) the effectiveness of the
device that is the subject of the application; and (3) full reports of
all preclinical and clinical information from investigations on the
safety and effectiveness of the device for which premarket approval is
sought.
A PMA should include valid scientific evidence obtained from well-
controlled clinical studies, with detailed data, in order to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
Applicants should submit any PMA in accordance with FDA's
``Premarket Approval (PMA) Manual.'' This manual is available upon
request from FDA, Center for Devices and Radiological Health, Division
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr.,
Rockville, MD 20850.
III. Request for Comments with Data
Interested persons may, on or before January 5, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
IV. Opportunity to Request a Change in Classification
Before requiring the filing of a PMA or a notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the act and Sec. 860.132 (21 CFR 860.132) to provide
an opportunity for interested persons to request a change in the
classification of the device based on new information relevant to its
classification. Any proceeding to reclassify the device will be under
the authority of section 513(e) of the act.
A request for a change in the classification of these devices is to
be in the form of a reclassification petition containing the
information required by Sec. 860.123 (21 CFR 860.123), including new
information relevant to the classification of the device, and shall,
under section 515(b)(2)(B) of the act, be submitted by September 22,
1995.
The agency advises that, to ensure timely filing of any such
petition, any request should be submitted to the Dockets Management
Branch (address above) and not to the address provided in
Sec. 860.123(b)(1). If a timely request for a change in the
classification of these devices is submitted, the agency will, by
November 6, 1995, after consultation with the appropriate FDA advisory
committee and by an order published in the Federal Register, either
deny the request or give notice of its intent to initiate a change in
the classification of the device in accordance with section 513(e) of
the act and Sec. 860.130 (21 CFR 860.130) of the regulations.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because FDA believes that there is little or no
interest in marketing these devices, the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VII. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
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46. Population Reports, ``Pregnancy Termination,'' Series F,
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47. Freeman, M. A. R., ``Current State of Joint Replacement,''
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48. Newton, S. E., ``Total Ankle Arthroplasty,'' Journal of Bone
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49. Stevens, P. S., ``Distal Humeral Prosthesis for the Elbow,''
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51. Flatt, A. E., ``Restoration of Rheumatoid Finger-Joint
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52. Flatt, A. E., ``Restoration of Rheumatoid Finger-Joint
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53. Flatt, A. E., ``Prosthetic Substitution for Rheumatoid
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54. Flatt, A. E., and G. W. Fischer, ``Biomechanical Factors in
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67. Page, D., J. H. Dumbleton, and E. H. Miller, ``A Study of
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68. Walker, P. S. et al., ``Development and Evaluation of a
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69. Walker P. S., and M. J. Erkman, ``Laboratory Evaluation of a
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70. Walker, P. S., ``Human Joints and their Artificial
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71. Nicolle, F., ``Modified Design of Encapsulated
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73. Griffiths, R. W., and F. V. Nicolle, ``Three Years'
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74. Burton, D. S., and D. J. Schurman, ``Hematogenous Infection
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75. Beckenbaugh, R. D. et al., ``Review and Analysis of
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76. Goldner, J. L. et al., ``Metacarpophalangeal Joint
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77. Goldner, J. L., and J. R. Urbaniak, ``The Clinical
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78. Hagert, C. G., ``Metacarpophalangeal Joint Implants II:
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79. Niebauer, J. J., and R. M. Landry, ``Dacron-Silicone
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The Hand, 3:55-61, 1971.
80. Swanson, B., ``Flexible Implant Arthroplasty for Arthritic
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Journal of Bone and Joint Surgery, 54A:435-455, 1972.
81. Swanson, A. B., ``Flexible Implant Arthroplasty in the
Hand,'' Clinical and Plastic Surgery, 3:141-157, 1976.
82. Hagert, C. G. et al., ``Metacarpophalangeal Joint
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Surgery, 19:147-157, 1975.
83. Mannerfelt, L., and K. Anderson, ``Silastic Arthroplasty of
the Metacarpophalangeal Joints in Rheumatoid Arthritis,'' Journal of
Bone and Joint Surgery, 57A:484-489, 1975.
84. Ferlic, D. C., M. L. Clayton, and M. Holloway,
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57A:991-994, 1975.
85. Aptekar, R. G., J. M. Davie, and H. S. Cattell, ``Foreign
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86. Hagert, C. G., ``Metacarpophalangeal Joint Implants,''
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226, 1975.
87. Weightman, S. S. et al., ``Environmental Fatigue Testing of
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Research, Symposium, 3:15-24, 1972.
88. Swanson, A. B., and J. H. Herndon, ``Flexible (Silicone)
Implant Arthroplasty of the Metacarpophalangeal Joint of the
Thumb,'' Journal of Bone and Joint Surgery, 59A:362-368, 1977.
89. Swanson, A. B., ``Implant Resection Arthroplasty of the
Proximal Interphalangeal Joint,'' Orthopedic Clinics of North
America, 4(4):1007-1209, 1973.
90. Braun, R. M., and J. Chandler, ``Quantitative Results
Following Implant Arthroplasty of the Proximal Finger Joints in the
Arthritic Hand,'' Clinical Orthopaedics and Related Research,
83:135-143, 1972.
91. Sivash, K. M., ``The Development of a Total Metal Prosthesis
for the Hip Joint from a Partial Joint Replacement,'' Reconstructive
Surgery and Traumatology, 11:53-62, 1969.
92. McKellop, H. A. et al., ``Wear Properties of Sialon Ceramics
and Delrin 150 Homopolymer Under Physiological Conditions,''
Transaction of the 4th Annual Meeting of the Society for
Biomaterials, April 29-May 2, 1978.
93. Dumbleton, J. H., ``Delrin as a Material for Joint
Prostheses--A Review,'' ``Corrosion and Degradation of Implant
Material, ASTM STP684,'' American Society for Testing Materials, pp.
41-60, 1978.
94. Insall, J. N. et al., ``A Comparison of 4 Models of Total
Knee Replacement Prostheses,'' Journal of Bone and Joint Surgery,
58A:754-765, September 1976.
95. Deburge, A., ``GUEPAR Hinge Prosthesis,'' Clinical
Orthopedics, 120:47-53, October 1976.
96. Engelbrecht, E. et al., ``Statistics of Total Knee
Replacement: Partial and Total Knee Replacement,'' Clinical
Orthopedics, 120:54-64, October 1976.
97. Freeman, P. A., ``Walldius Arthroplasty,'' Clinical
Orthopedics, 94:85-91, July-August 1973.
98. Phillips, H., and J. G. Taylor, ``The Walldius Hinge
Arthroplasty,'' Journal of Bone and Joint Surgery, 57B:51-62, 1975.
99. Habermann, E. T., S. D. Deutsch, and G. D. Rovere, ``Knee
Arthroplasty with the Use of the Walldius Total Knee Prosthesis,''
Clinical Orthopedics, 94:72-84, July-August 1973.
100. Wilson, F. C., and G. L. Venters, ``Results of Knee
Replacement with the Walldius Prosthesis,'' Clinical Orthopedics,
20:39-46, October 1976.
101. Blundell-Jones, G., ``Total Knee Replacement--The Walldius
Hinge,'' Clinical Orthopedics, 94:50:57, July-August 1973.
102. Bain, A. M., ``Replacement of the Knee Joint with the
Walldius Prosthesis Using Cement Fixation,'' Clinical Orthopedics,
94:65-71, July-August 1973.
103. Brady, T. A., and J. N. Garber, ``Knee Joint Replacement
Using Shiers Knee Hinge,'' Journal of Bone and Joint Surgery,
56A:1610-1614, December 1974.
104. Watson, J. R., H. Wood, and R. C. J. Hill, ``The Shiers
Arthroplasty of the Knee,'' Journal of Bone and Joint Surgery,
58B:300-304, August 1976.
105. Kettlekamp, D. B., ``Total Joint Replacement,''
``Proceedings of the Workshop: Mechanical Failure of Total Joint
Replacement, Atlanta, June 1978,'' The Sterring Committee, American
Academy of Orthopaedic Surgeons, Chicago, 1978.
106. Chand, K., ``The Knee Joint in Rheumatoid Arthritis III.
Treatment by Hinged Total Knee Prosthetic Replacement,''
International Surgery, 59:600-607, November-December 1974.
107. Deburge, A., J. H. Aubriot, and J. P. Genet, ``Current
Status of a Hinge Prosthesis (GUEPAR),'' Clinical Orthopedics and
Related Research, 145:91-93, November-December 1979.
108. Arden, G. P., and B. A. Kamdar, ``Complications of
Arthroplasty of the Knee,'' in ``Total Knee Replacement,'' chaired
by L. G. P. Shiers, Mechanical Engineering Publications, Ltd.,
London, pp. 118-122, 1975.
109. Kaushal, S. P. et al., ``Complications Following Total Knee
Replacements,'' Clinical Orthopedics and Related Research, 121:181-
187, November-December 1976.
110. Van Camp, D. H., H. W. Croon, and J. Lindwer, ``Influence
of Cyclic Loading on
[[Page 46737]]
Mechanical Loosening of Hinged Knee Prostheses,'' Engineering in
Medicine, 4:235-239, 1978.
111. Walker, P. S., ``Human Joints and Their Artificial
Replacements,'' Charles C. Thomas, publisher, Springfield, IL, p.
321, 1977.
112. Wagner, J., and R. Bourgois, ``Biomedical Study of the
Hinged Knee Prosthesis,'' Clinical Orthopedics and Related Research,
102:188-193, July-August 1974.
113. Swanson, S. A. V., M. A. R. Freeman, and J. C. Health,
``Laboratory Tests on Total Joint Replacement Prostheses,'' Journal
of Bone and Joint Surgery, 55B:759-773, November 1973.
114. Brodersen, M. P. et al., ``Arthrodesis of the Knee
Following Failed Total Knee Arthroplasty,'' Journal of Bone and
Joint Surgery, 61A:181-185, March 1979.
115. Hanslik, L., ``Das patellofemorale Gleitlagerbeim total
kniegelenkersatz. Vorlaeufige Mitteilung ueber die implantation
einer modifizierten McKeever-Endoprothese in Kombination mit der
Alloarthroplastik nach Young,'' Zeitschrift fuer Orthopaedic and
Ihre Gremzgebicte, 109:435-440, 1971.
116. Young, H. H., ``Use of Hinged Vitallium Prosthesis for
Arthroplasty of the Knee. A Preliminary Report,'' Journal of Bone
and Joint Surgery, 45A:1627-1641, 1963.
117. Girzadas, D. V. et al., ``Performance of a Hinged Metal
Knee Prosthesis: A Case Report With a Followup of 3.5 years and
Histological and Metallurgical Data,'' Journal of Bone and Joint
Surgery, 50A:355-364, 1968.
118. Friedebold, G., ``First Experiences With the Young Knee in
Synovectomy and Arthroplasty in Rheumatoid Arthritis,'' edited by
Chapchal, G., G. Thieme, Verlag, Stuttgart, pp. 85-86, 1967.
119. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the
Knee Joint. Indications and Results,'' Reconstructive Surgery and
Traumatology, 12:181-196, 1971.
120. Young, H. H., ``Reconstruction of Knee Joint With Young-
Type Hinged Vitallium Prosthesis,'' Reconstructive Surgery and
Traumatology, 12:176-180, 1971.
121. Hanslik, L., ``First Experience on Knee Joint Replacement
Using the Young Hinged Prosthesis Combined with a Modification on
the McKeever Patella Prosthesis,'' Clinical Orthopedics, 94:115-121,
1973.
122. Fox, K. W., ``Geometric Total Knee Arthroplasty: Local
Complications,'' Texas Medicine, 72:92-97, 1976.
123. Platt, G., and C. Pepler, ``Mould Arthroplasty of the Knee.
A Ten-Year Followup Study,'' Journal of Bone and Joint Surgery,
51B:76-87, 1969.
124. Aufranc, O. E., and W. N. Jones, ``Mold Arthroplasty of the
Knee,'' Journal of Bone and Joint Surgery, 40A:1431, 1958.
125. Jones, W. N., ``Mold Arthroplasty of the Knee Joint,''
Clinical Orthopedics, 66:82-89, 1969.
126. Riley, L. H., Jr., ``The Evolution of Total Knee
Arthroplasty,'' Clinical Orthopedics, 120:7-10, 1976.
127. Kitridou, R. C. et al., ``Recurrent Hemarthrosis After
Prosthetic Knee Arthroplasty,'' Arthritis and Rheumatism, 12(5):520-
528, 1969.
128. Turner, R. H., and O. E. Aufranc, ``Femoral Stem
Replacement Arthroplasty of the Knee,'' Surgical Clinics of North
America, 49(4):917-927, 1969.
129. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the
Knee Joint. Indications and Results,'' Reconstructive Surgery and
Traumatology, 12:181-196, 1971.
130. Yeoman, P. M., ``Arthroplasty of the Knee: A Comparative
Study of Platt's Mold and McKee Arthroplasties,'' Journal of Bone
and Joint Surgery, 53B(1):150, 1971.
131. Turner, R. A. et al., ``Arthroplasty of the Knee With
Tibial and/or Femoral Metallic Implants in Rheumatoid Arthritis,''
Arthritis and Rheumatism, 15:1-15, 1972.
132. Groeneveld, H. B., ``Combined Femorotibial-Patellar
Endoprosthesis of the Knee Joint Preserving the Ligaments,'' Acta
Orthopaedica Belgica, 39:210-215, 1973.
133. Kettelkamp, D. B., ``Functional Analysis of the Knee,'' in
``Workshop on Fundamental Studies for Internal Structural
Prostheses,'' chaired by F. W. Clippinger, Jr., National Academy of
Sciences, Washington, DC pp., 19-23, 1973.
134. Sbarbaro, J. L., Jr., ``Femoral Condylar Mold Arthroplasty
in 150 Rheumatoid Knees,'' Acta Orthopaedica Belgica, 39:138-147,
1973.
135. Wilde, A. H. et al., ``Current Use of Geometric Knee
Replacement Arthroplasty,'' Orthopedic Review, 3(3):25-31, 1974.
136. Romero, R. L., and E. M. Burgess, ``Total Shoulder
Replacement,'' Journal of Bone and Joint Surgery, 57A:1033, 1975.
137. Fenlin, J. M., Jr., ``Total Shoulder Prosthesis,'' Journal
of Bone and Joint Surgery, 58A:735, 1976.
138. Fenlin, J. M., Jr., ``Total Glenohumeral Joint
Replacement,'' Orthopedic Clinics of North America, 6:565-583, 1975.
139. Linscheid, R. L., and R. H. Cofield, ``Total Shoulder
Arthroplasty: Experimental but Promising,'' Geriatrics, 64-69, April
1976.
140. Cofield, R. H., ``Status of Total Shoulder Arthroplasty,''
Archives of Surgery, 12:1088-1091, 1971.
141. Buechel, F. F., M. J. Pappas, and A. F. DePalma,
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Biomechanical and Surgical Rationale,'' Journal of Biomedical
Materials Research, 12:89-144, 1978.
142. Cofield, R. H., and R. N. Stauffer, ``The Bickel
Glenohumeral Arthroplasty,'' in ``Joint Replacement in the Upper
Limb: Institution of Mechanical Engineers, 1977-1985,'' Mechanical
Engineering Publications Ltd., Great Britain, pp. 15-20, 1977.
143. Cofield, R. H., ``Total Shoulder Arthroplasty: The Current
State of Development,'' in ``DHEW/RSA Workshop on Internal Joint
Replacement,'' edited by C. L. Compere and J. L. Lewis, Chicago, pp.
33-37, 1977.
144. Gschwend, N., H. Scheier, and A. Bahler, ``GSB Elbow,
Wrist, MP and PIP Joints,'' in ``Proceedings of Joint Replacement in
the Upper Limb Conference,'' sponsored by the Institute of
Mechanical Engineering, April 18-20, pp. 107-116, 1977.
145. Peizer, E., ``Special Programs: VA Prosthetics Center
Research, Development, and Evaluation Program,'' Bulletin of
Prosthetics Research, 10-22:469-477, Fall 1974.
146. ``Evaluation of the Ortho-Walk Type B Pneumatic Orthosis on
Thirty-Seven Paraplegic Patients,'' Report by the Committee on
Prosthetics Research and Development/Committee on Prosthetic-
Orthotic Education, National Academy of Sciences, Washington, DC,
1976. Supported by the Veterans' Administration and the Social
Rehabilitation Service, Department of Health, Education, and
Welfare.
List of Subjects
21 CFR Part 864
Blood, Medical devices, Packaging and containers.
21 CFR Parts 868, 870, 872, 876, 880, 882, 884, 888, and 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 864, 868, 870, 872, 876, 880, 882, 884, 888,
and 890 be amended as follows:
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
1. The authority citation for 21 CFR part 864 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 864.5220 is amended by revising paragraph (c) to read as
follows:
Sec. 864.5220 Automated differential cell counter.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before (date 90 days after date of
publication of the final rule based on this proposed rule). For any
automated differential cell counter described in paragraph (b)(2) of
this section that was in commercial distribution before May 28, 1976,
or that has, on or before (date 90 days after date of publication of
the final rule based on this proposed rule), been found to be
substantially equivalent to an automated differential cell counter
described in paragraph (b)(2) of this section that was in commercial
distribution before May 28, 1976. Any other automated differential cell
counter described in paragraph (b)(2) of this section shall have an
approved PMA or declared
[[Page 46738]]
completed PDP in effect before being placed in commercial distribution.
PART 868--ANESTHESIOLOGY DEVICES
3. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
4. Section 868.5400 is amended by revising paragraph (c) to read as
follows:
Sec. 868.5400 Electroanesthesia apparatus.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before (date 90 days after date of
publication of the final rule based on this proposed rule) for any
electroanesthesia apparatus that was in commercial distribution before
May 28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to a electroanesthesia apparatus that was in commercial
distribution before May 28, 1976. Any other electroanesthesia apparatus
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
PART--870 CARDIOVASCULAR DEVICES
5. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
6. Section 870.1350 is amended by revising paragraph (c) to read as
follows:
Sec. 870.1350 Catheter balloon repair kit.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before (date 90 days after date of
publication of the final rule). For any catheter balloon repair kit
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to a catheter balloon
repair kit that was in commercial distribution before May 28, 1976. Any
other catheter balloon repair kit shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
7. Section 870.1360 is amended by revising paragraph (c) to read as
follows:
Sec. 870.1360 Trace microsphere.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before (date 90 days after date of
publication of the final rule). For any trace microsphere that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a trace microsphere that was in
commercial distribution before May 28, 1976. Any other trace
microsphere shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
8. Section 870.3850 is amended by revising paragraph (c) to read as
follows:
Sec. 870.3850 Carotid sinus nerve stimulator.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any carotid sinus nerve stimulator
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to a carotid sinus
nerve stimulator that was in commercial distribution before May 28,
1976. Any other carotid sinus nerve stimulator shall have an approved
PMA or a declared completed PDP in effect before being placed in
commercial distribution.
9. Section 870.5300 is amended by revising paragraph (c) to read as
follows:
Sec. 870.5300 DC-defibrillator (including paddles).
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule). For any DC-defibrillator (including
paddles) described in paragraph (b)(1) of this section that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a DC-defibrillator (including
paddles) described in paragraph (b)(1) of this section that was in
commercial distribution before May 28, 1976. Any other DC-defibrillator
(including paddles) described in paragraph (b)(1) of this section shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.
PART 872--DENTAL DEVICES
10. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
11. Section 872.3400 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3400 Karaya and sodium borate with or without acacia denture
adhesive.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any karaya and sodium borate with or
without acacia denture adhesive that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a karaya and sodium borate with or without acacia denture
adhesive that was in commercial distribution before May 28, 1976. Any
other karaya and sodium borate with or without acacia denture adhesive
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
12. Section 872.3420 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3420 Carboxymethylcellulose sodium and cationic
polyacrylamide polymer denture adhesive.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any carboxymethylcellulose sodium
and cationic polyacrylamide polymer denture adhesive that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a carboxymethylcellulose sodium and
cationic polyacrylamide polymer denture adhesive that was in
[[Page 46739]]
commercial distribution before May 28, 1976. Any other
carboxymethylcellulose sodium and cationic polyacrylamide polymer
denture adhesive shall have an approved PMA or a declared completed PDP
in effect before being placed in commercial distribution.
13. Section 872.3480 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3480 Polyacrylamide polymer (modified cationic) denture
adhesive.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any polyacrylamide polymer (modified
cationic) denture adhesive that was in commercial distribution before
May 28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to a polyacrylamide polymer (modified cationic) denture
adhesive that was in commercial distribution before May 28, 1976. Any
other polyacrylamide polymer (modified cationic) denture adhesive shall
have an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
14. Section 872.3500 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any polyvinylmethylether maleic
anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium
(NACMC) denture adhesive that was in commercial distribution before May
28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to a polyvinylmethylether maleic anhydride (PVM-MA), acid
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive
that was in commercial distribution before May 28, 1976. Any other
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and
carboxymethylcellulose sodium (NACMC) denture adhesive shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
15. Section 872.3560 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3560 OTC denture reliner.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any OTC denture reliner that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to an OTC denture reliner that was in
commercial distribution before May 28, 1976. Any other OTC denture
reliner shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
16. Section 872.3820 is amended by revising paragraph (c) to read
as follows:
Sec. 872.3820 Root canal filling resin.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any root canal filling resin
described in paragraph (b)(2) of this section that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a root canal filling resin described in
paragraph (b)(2) of this section that was in commercial distribution
before May 28, 1976. Any other root canal filling resin shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
17. The authority citation for 21 CFR part 876 is revised to read
as follows:
Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,
360e, 360j, 360l, 371).
18. Section 876.5220 is amended by revising paragraph (c) to read
as follows:
Sec. 876.5220 Colonic irrigation system.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any colonic irrigation system
described in paragraph (b)(2) of this section that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a colonic irrigation system described in
paragraph (b)(2) of this section that was in commercial distribution
before May 28, 1976. Any other colonic irrigation system shall have an
approved PMA in effect before being placed in commercial distribution.
19. Section 876.5270 is amended by revising paragraph (c) to read
as follows:
Sec. 876.5270 Implanted electrical urinary continence device.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any implanted electrical urinary
continence device that was in commercial distribution before May 28,
1976, or that has, on or before (date 90 days after date of publication
of the final rule), been found to be substantially equivalent to an
implanted electrical urinary continence device that was in commercial
distribution before May 28, 1976. Any other implanted electrical
urinary continence device shall have an approved PMA or a declared
completed PDP in effect before being place in commercial distribution.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
20. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
21. Section 880.5760 is amended by revising paragraph (c) to read
as follows:
Sec. 880.5760 Chemical cold pack snakebite kit.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any chemical cold pack snakebite kit
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date
[[Page 46740]]
of publication of the final rule), been found to be substantially
equivalent to a chemical cold pack snakebite kit that was in commercial
distribution before May 28, 1976. Any other chemical cold pack
snakebite kit shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
PART 882--NEUROLOGICAL DEVICES
22. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
23. Section 882.1825 is amended by revising paragraph (c) to read
as follows:
Sec. 882.1825 Rheoencephalograph.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any rheoencephalograph that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a rheoencephalograph that was in
commercial distribution before May 28, 1976. Any other
rheoencephalograph shall have an approved PMA or a declared completed
PDP in effect before being placed in commercial distribution.
24. Section 882.5150 is amended by revising paragraph (c) to read
as follows:
Sec. 882.5150 Intravascular occluding catheter.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any intravascular occluding catheter
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to a intravascular
occluding catheter that was in commercial distribution before May 28,
1976. Any other intravascular occluding catheter shall have an approved
PMA or a declared completed PDP in effect before being place in
commercial distribution.
25. Section 882.5850 is amended by revising paragraph (c) to read
as follows:
Sec. 882.5850 Implanted spinal cord stimulator for bladder evacuation.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any implanted spinal cord stimulator
for bladder evacuation that was in commercial distribution before May
28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to an implanted spinal cord stimulator for bladder
evacuation that was in commercial distribution before May 28, 1976. Any
other implanted spinal cord stimulator for bladder evacuation shall
have an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
26. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
27. Section 884.2050 is amended by revising paragraph (c) to read
as follows:
Sec. 884.2050 Obstetric data analyzer.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any obstetric data analyzer that was
in commercial distribution before May 28, 1976, or that has, on or
before (date 90 days after date of publication of the final rule), been
found to be substantially equivalent to an obstetrical data analyzer
that was in commercial distribution before May 28, 1976. Any other
obstetric data analyzer shall have an approved PMA or a declared
completed PDP in effect before being place in commercial distribution.
28. Section 884.2620 is amended by revising paragraph (c) to read
as follows:
Sec. 884.2620 Fetal electroencephalographic monitor.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any fetal electroencephalographic
monitor that was in commercial distribution before May 28, 1976, or
that has, on or before (date 90 days after date of publication of the
final rule), been found to be substantially equivalent to a fetal
electroencephalographic monitor in commercial distribution before May
28, 1976. Any other fetal electroencephalographic monitor shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
29. Section 884.2685 is amended by revising paragraph (c) to read
as follows:
Sec. 884.2685 Fetal scalp clip electrode and applicator.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any fetal scalp clip electrode and
applicator that was in commercial distribution before May 28, 1976, or
that has, on or before (date 90 days after date of publication of the
final rule), been found to be substantially equivalent to a fetal scalp
clip electrode and applicator that was in commercial distribution
before May 28, 1976. Any other fetal scalp clip electrode and
applicator shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
30. Section 884.4250 is amended by revising paragraph (c) to read
as follows:
Sec. 884.4250 Expandable cervical dilator.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any expandable cervical dilator that
was in commercial distribution before May 28, 1976, or that has, on or
before (date 90 days after date of publication of the final rule), been
found to be substantially equivalent to an expandable cervical dilator
that was in commercial distribution before May 28, 1976. Any other
expandable cervical dilator shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
31. Section 884.4270 is amended by revising paragraph (c) to read
as follows:
[[Page 46741]]
Sec. 884.4270 Vibratory cervical dilators.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any vibratory cervical dilator that
was in commercial distribution before May 28, 1976, or that has, on or
before (date 90 days after date of publication of the final rule), been
found to be substantially equivalent to a vibratory cervical dilator
that was in commercial distribution before May 28, 1976. Any other
vibratory cervical dilator shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
32. Section 884.5050 is amended by revising paragraph (c) to read
as follows:
Sec. 884.5050 Metreurynter-balloon abortion system.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any metreurynter-balloon abortion
system that was in commercial distribution before May 28, 1976, or that
has, on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to a metreurynter-
balloon abortion system that was in commercial distribution before May
28, 1976. Any other metreurynter-balloon abortion system shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
33. Section 884.5225 is amended by revising paragraph (c) to read
as follows:
Sec. 884.5225 Abdominal decompression chamber.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any abdominal decompression chamber
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to an abdominal
decompression chamber that was in commercial distribution before May
28, 1976. Any other abdominal decompression chamber shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
PART 888--ORTHOPEDIC DEVICES
34. The authority citation for 21 CFR part 888 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
35. Section 888.3120 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3120 Ankle joint metal/polymer non-constrained cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any ankle joint metal/polymer non-
constrained cemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a ankle joint metal/polymer non-constrained cemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other ankle joint metal/polymer non-constrained cemented prosthesis
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
36. Section 888.3180 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any elbow joint humeral (hemi-elbow)
metallic uncemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a elbow joint humeral (hemi-elbow) metallic uncemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other elbow joint humeral (hemi-elbow) metallic uncemented prosthesis
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
37. Section 888.3200 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3200 Finger joint metal/metal constrained uncemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule), for any finger joint metal/metal
constrained uncemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a finger joint metal/metal constrained uncemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other finger joint metal/metal constrained uncemented prosthesis shall
have an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
38. Section 888.3210 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3210 Finger joint metal/metal constrained cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any finger joint metal/metal
constrained cemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a finger joint metal/metal constrained cemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other finger joint metal/metal constrained cemented prosthesis shall
have an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
39. Section 888.3220 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3220 Finger joint metal/polymer constrained cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90
[[Page 46742]]
days after date of publication of the final rule) for any finger joint
metal/polymer constrained cemented prosthesis that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a finger joint metal/polymer constrained
cemented prosthesis that was in commercial distribution before May 28,
1976. Any other finger joint metal/polymer constrained cemented
prosthesis shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
40. Section 888.3300 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3300 Hip joint metal constrained cemented or uncemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any hip joint metal constrained
cemented or uncemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a hip joint metal constrained cemented or uncemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other hip joint metal constrained cemented or uncemented prosthesis
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
41. Section 888.3310 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3310 Hip joint metal/polymer constrained cemented or
uncemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any hip joint metal/polymer
constrained cemented or uncemented prosthesis that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a hip joint metal/polymer constrained
cemented or uncemented prosthesis that was in commercial distribution
before May 28, 1976. Any other hip joint metal/polymer constrained
cemented or uncemented prosthesis shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
42. Section 888.3370 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3370 Hip joint (hemi-hip) acetabular metal cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any hip joint (hemi-hip) acetabular
metal cemented prosthesis that was in commercial distribution before
May 28, 1976, or that has, on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to a hip joint (hemi-hip) acetabular metal cemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other hip joint metal (hemi-hip) acetabular metal cemented prosthesis
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
43. Section 888.3380 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/
polyacetal cemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any hip joint femoral (hemi-hip)
trunnion-bearing metal/polyacetal cemented prosthesis that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a hip joint femoral (hemi-hip)
trunnion-bearing metal/polyacetal cemented prosthesis that was in
commercial distribution before May 28, 1976. Any other hip joint
femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented
prosthesis shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
44. Section 888.3480 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3480 Knee joint femorotibial metallic constrained cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any knee joint femorotibial metallic
constrained cemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication in the Federal Register of the final rule based on this
proposed rule), been found to be substantially equivalent to a knee
joint femorotibial metallic constrained cemented prosthesis that was in
commercial distribution before May 28, 1976. Any other knee joint
femorotibial metallic constrained cemented prosthesis shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
45. Section 888.3540 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3540 Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any knee joint patellofemoral
polymer/metal semi-constrained cemented prosthesis that was in
commercial distribution before May 28, 1976, or that has, on or before
(date 90 days after date of publication of the final rule), been found
to be substantially equivalent to a knee joint patellofemoral polymer/
metal semi-constrained cemented prosthesis that was in commercial
distribution before May 28, 1976. Any other knee joint patellofemoral
polymer/metal semi-constrained cemented prosthesis shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.
46. Section 888.3550 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3550 Knee joint patellofemorotibial polymer/metal/metal
constrained cemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any knee joint patellofemorotibial
polymer/metal/metal constrained cemented prosthesis
[[Page 46743]]
that was in commercial distribution before May 28, 1976, or that has,
on or before (date 90 days after date of publication of the final
rule), been found to be substantially equivalent to a knee joint
patellofemorotibial polymer/metal/metal constrained cemented prosthesis
that was in commercial distribution before May 28, 1976. Any other knee
joint patellofemorotibial polymer/metal/metal constrained cemented
prosthesis shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
47. Section 888.3570 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3570 Knee joint femoral (hemi-knee) metallic uncemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any knee joint femoral (hemi-knee)
metallic uncemented prosthesis that was in commercial distribution
before May 28, 1976, or that has, on or before (date 90 days after date
of publication of the final rule), been found to be substantially
equivalent to a knee joint femoral (hemi-knee) metallic uncemented
prosthesis that was in commercial distribution before May 28, 1976. Any
other knee joint femoral (hemi-knee) metallic uncemented prosthesis
shall have an approved PMA or a declared completed PDP in effect before
being placed in commercial distribution.
48. Section 888.3580 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing
uncemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any knee joint patellar (hemi-knee)
metallic resurfacing uncemented prosthesis described in paragraph
(b)(2) of this section that was in commercial distribution before May
28, 1976, or that has on or before (date 90 days after date of
publication of the final rule), been found to be substantially
equivalent to a knee joint patellar (hemi-knee) metallic resurfacing
uncemented prosthesis that was in commercial distribution before May
28, 1976. Any other knee joint patellar (hemi-knee) metallic
resurfacing uncemented prosthesis shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
49. Section 888.3640 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3640 Shoulder joint metal/metal or metal/polymer constrained
cemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any shoulder joint metal/metal or
metal/polymer constrained cemented prosthesis that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a shoulder joint metal/metal or metal/
polymer constrained cemented prosthesis that was in commercial
distribution before May 28, 1976. Any other shoulder joint metal/metal
or metal/polymer constrained cemented prosthesis shall have an approved
PMA or a declared completed PDP in effect before being placed in
commercial distribution.
50. Section 888.3680 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented
prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any shoulder joint glenoid (hemi-
shoulder) metallic cemented prosthesis that was in commercial
distribution before May 28, 1976, or that has, on or before (date 90
days after date of publication of the final rule), been found to be
substantially equivalent to a shoulder joint glenoid (hemi-shoulder)
metallic cemented prosthesis that was in commercial distribution before
May 28, 1976. Any other shoulder joint glenoid (hemi-shoulder) metallic
cemented prosthesis shall have an approved PMA or a declared completed
PDP in effect before being placed in commercial distribution.
51. Section 888.3790 is amended by revising paragraph (c) to read
as follows:
Sec. 888.3790 Wrist joint metal constrained cemented prosthesis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any wrist joint metal constrained
cemented prosthesis that was in commercial distribution before May 28,
1976, or that has, on or before (date 90 days after date of publication
of the final rule), been found to be substantially equivalent to a
wrist joint metal constrained cemented prosthesis that was in
commercial distribution before May 28, 1976. Any other wrist joint
metal constrained cemented prosthesis shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.
PART 890--PHYSICAL MEDICINE DEVICES
52. The authority citation for 21 CFR part 890 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
53. Section 890.3610 is amended by revising paragraph (c) to read
as follows:
Sec. 890.3610 Rigid pneumatic structure orthosis.
* * * * *
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before (date 90 days after date of
publication of the final rule) for any rigid pneumatic structure
orthosis that was in commercial distribution before May 28, 1976, or
that has, on or before (date 90 days after date of publication of the
final rule), been found to be substantially equivalent to a rigid
pneumatic structure orthosis that was in commercial distribution before
May 28, 1976. Any other rigid pneumatic structure orthosis shall have
an approved PMA or a declared completed PDP in effect before being
placed in commercial distribution.
Dated: August 9, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-22027 Filed 9-6-95; 8:45 am]
BILLING CODE 4160-01-F
