[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Notices]
[Pages 32355-32358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15450]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0417]
Order for Certain Class III Devices; Submission of Safety and
Effectiveness Information; Group 2
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is revising the
schedule for submission of summaries and citations for 3 devices
included in the order requiring manufacturers of 31 class III devices
(Group 2) to submit to FDA a summary of, and a citation to, all
information known or otherwise available to them respecting such
devices, including adverse safety or effectiveness information
concerning the devices that have not been submitted under the Federal
Food, Drug, and Cosmetic Act (the act). In response to comments
received on the August 14, 1995, order and in order to facilitate the
review process, FDA is grouping three cardiovascular devices with
related uses together and is changing the date by which summaries and
citations are to be submitted for them to February 14, 1998. As a
reminder to device manufacturers, FDA is also reprinting the due dates
for all other devices listed in the August 14, 1995, order.
DATES: Summaries and citations must be submitted by the dates listed
below.
[[Page 32356]]
ADDRESSES: Submit summaries and citations to the Document Mail Center
(HFZ-401), Food and Drug Administration, Center for Devices and
Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Doreen M. Melling, Center for Devices
and Radiological Health (HFZ-404), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
Section 513 of the act (21 U.S.C. 360c) requires the classification
of medical devices into one of three 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. This notice refers to both the class III devices
that were on the market before May 28, 1976, and the substantially
equivalent devices that were marketed on or after that date, as
``preamendment devices''.
Section 515(b) of the act (21 U.S.C. 360e(b)) establishes the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. However the submission of a
premarket approval application (PMA), or a notice of completion of a
product development protocol (PDP), is not required until 90 days after
FDA issues a final rule requiring premarket approval for the device, or
30 months after final classification of the device, whichever is later.
Also, such a device is exempt from the investigational device exemption
(IDE) regulations (21 CFR part 812) until the date stipulated by FDA in
the final rule requiring premarket approval for that device. 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 only for investigational use if the
manufacturer, importer, or other sponsor of the device complies with
the IDE regulations.
To date, FDA has issued final rules requiring the submission of
PMA's for 52 preamendment class III devices. Additionally, FDA has
issued proposed rules for 12 other devices. There are 68 remaining
preamendment class III devices for which FDA has not yet initiated any
action requiring the submission of PMA's. The original number of
approximately 140 preamendments class III devices can be accounted for
by past reclassification actions.
The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629)
changed the definition of class II devices from those for which a
performance standard is necessary to provide reasonable assurance of
safety and effectiveness to those for which there is sufficient
information to establish special controls to provide such assurance.
Special controls include performance standards, postmarket
surveillance, patient registries, guidelines (including guidelines for
the submission of clinical data in premarket notification submissions
in accordance with section 510(k) of the act (21 U.S.C. 360(k)),
recommendations, and other appropriate actions the agency deems
necessary to provide such assurance. Thus, the SMDA modified the
definition of class II devices to permit reliance on special controls,
rather than performance standards alone, to provide reasonable
assurance of safety and effectiveness.
The SMDA also added new section 515(i) to the act. This section
requires FDA to order manufacturers of preamendment class III devices
for which no final regulation requiring the submission of PMA's has
been issued to submit to the agency a summary of, and a citation to,
any information known or otherwise available to them respecting such
devices, including adverse safety and effectiveness information which
has not been submitted under section 519 of the act (21 U.S.C. 360i).
Section 519 of the act requires manufacturers, importers, or
distributors to maintain records and to report information that
reasonably suggests that one of its marketed devices may have caused or
contributed to a death or serious injury or that a malfunction of the
device is likely to cause death or serious injury on recurrence.
Section 515(i) of the act also directs FDA to publish a regulation
before December 1, 1995, for each device subject to section 515(i),
either revising the classification of the device into class I or class
II or requiring the device to remain in class III. Finally, section
515(i) of the act requires that, within 12 months after publication of
a regulation retaining a device in class III, FDA is to establish a
schedule for the promulgation of a rule requiring the submission of
PMA's for the device.
In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced
its strategy for addressing the 116 remaining preamendment class III
devices. In this notice, FDA made available a document setting forth
its strategy for implementing the provisions of the SMDA that require
FDA to review the classification of certain class III devices, and
either reclassify the devices into class I or class II or retain them
in class III. Under this plan, the agency divided the universe of
preamendment class III devices into three groups: 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; Group
2 devices are devices that FDA believes have a high potential for being
reclassified into class II; and Group 3 devices are devices that FDA
believes are currently in commercial distribution and are not likely
candidates for reclassification. There are a total of 43, 31, and 42
(15 high priority) devices in Groups 1, 2, and 3, respectively.
In the May 6, 1994, notice, FDA announced its intention to call for
the submission of PMA's for the 15 highest priority devices in Group 3,
and for all Group 1 devices. In the Federal Register of September 27,
1996 (61 FR 50704), was published a final rule requiring the filing of
a PMA or a notice of completion of a PDP for 41 class III devices
(Group 1 device). In the Federal Register of May 6, 1994, notice, the
agency also announced its intention to issue an order under section
515(i) of the act for the remaining Group 3 devices and all of the
Group 2 devices.
In the Federal Register of August 14, 1995 (60 FR 41986), FDA
issued an order requiring manufacturers of the 31 devices in Group 2 to
submit a summary of, and citation to, all safety and effectiveness
information known or otherwise available to them respecting such
devices, including adverse safety and effectiveness information
concerning the devices which had not been submitted under section 519
of the act. Under section 515(i) of the act, FDA is authorized to
require the submission of the adverse safety and effectiveness
information identified in the summary and citation submitted in
response to this order, if such information is available. In this
notice, FDA is grouping three devices with related uses together and is
revising the date by which summaries and citations are to be submitted.
The summaries for the cardiopulmonary bypass arterial line blood filter
(originally due by August 14, 1997), the cardiopulmonary bypass
pulsatile flow generator (originally due by August 14, 1998), and the
cardiopulmonary bypass oxygenator (originally due by August 14, 1997)
are now due by February 14, 1998. Based upon the information submitted
in
[[Page 32357]]
response to this order, FDA will issue a proposed regulation for each
device either proposing its reclassification into class I or class II,
or retaining the device in class III. The due dates for summaries and
citations for the other Group 2 devices remain the same and are listed
below.
II. Statutory Authority and Enforcement
In addition to the provisions of section 515(i) of the SMDA
described in section I of this document, this order is issued under
section 519 of the act, as implemented by Sec. 860.7(g)(2) (21 CFR
860.7(g)(2)). This regulation authorizes FDA to require reports or
other information bearing on the classification of a device. Section
519 of the act also requires the reporting of any death or serious
injury caused by a device or by its malfunction.
Failure to comply with this order is a prohibited act under section
301(q) of the act (21 U.S.C. 331(q)), and the agency will use its
enforcement powers to deter noncompliance. Violations under section 301
of the act may be subject to seizure or injunction under sections
302(a) and 304(a) of the act (21 U.S.C. 332(a) and 334(a)). In
addition, violations under section 301 of the act may be subject to
civil penalties under section 303(f) of the act (21 U.S.C. 333(f)) and
criminal prosecution under section 303(a) of the act.
III. Order
The agency is hereby issuing this order under sections 515(i) and
519 of the act and Sec. 860.7(g)(1) of the regulations. Under the
order, the required information shall be submitted by the dates listed
below so that FDA may begin promptly the process established by section
515(i) of the act to either revise or sustain the current
classification of these devices. The three devices listed with a
February 14, 1998, due date are the devices whose due date is being
revised. The remaining due dates are reprinted here from the August 14,
1995, order as a reminder to device manufacturers.
A. Deadlines for Submission of Information
For the following eight devices, the required information was to be
submitted by August 14, 1996:
1. Sec. 864.7250 Erythropoietin assay.
2. Sec. 864.7300 Fibrin monomer paracoagulation test.
3. Sec. 876.3630 Penile rigidity implant.
4. Sec. 878.5360 Tweezer-type epilator.
5. Sec. 884.1060 Endometrial aspirator.
6. Sec. 884.1100 Endometrial brush.
7. Sec. 884.1185 Endometrial washer.
8. Sec. 886.3920 Eye valve implants.
For the following nine devices, the required information was to be
submitted by February 14, 1997:
9. Sec. 866.3305 Herpes simplex virus serological reagents.
10. Sec. 866.3510 Rubella virus serological reagents.
11. Sec. 870.3620 Pacemaker lead adaptor.
12. Sec. 872.6080 Airbrush.
13. Sec. 876.4480 Electrohydraulic lithotriptor.
14. Sec. 878.3610 Esophageal prosthesis.
15. Sec. 878.3720 Tracheal prosthesis.
16. Sec. 884.4100 Endoscopic electrocautery and accessories.
17. Sec. 884.4150 Bipolar endoscopic coagulator-cutter and
accessories.
For the following eight devices, the required information shall be
submitted by August 14, 1997:
18. Sec. 868.1150 Indwelling blood carbon dioxide partial pressure
analyzer.
19. Sec. 868.1170 Indwelling blood hydrogen ion concentration.
analyzer.
20. Sec. 868.1200 Indwelling blood oxygen partial pressure
analyzer.
21. Sec. 870.3680 Cardiovascular permanent pacemaker electrodes.
22. Sec. 876.5860 High permeability hemodialysis system.
23. Sec. 878.5650 Topical 02 chamber.
24. Sec. 882.5940 Electroconvulsive therapy device.
25. Sec. 888.3660 Shoulder semi-constrained.
For the following three devices, the required information shall be
submitted by February 14, 1998:
26. Sec. 870.4260 Cardiopulmonary bypass arterial line blood
filter. (Originally due August 14, 1997.)1
27. Sec. 870.4320 Cardiopulmonary bypass pulsatile flow generator.
(Originally due on August 14, 1998.)1
28. Sec. 870.4350 Cardiopulmonary bypass oxygenator. (Originally
due on August 14, 1997.)\1\
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\1\ Revised due date.
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For the following three devices, the required information shall be
submitted by August 14, 1998:
29. Sec. 870.3710 Pacemaker repair or replacement material.
30. Sec. 870.5200 External cardiac compressor.
31. Sec. 876.5540 Implanted blood access device.
B. Required Contents of Submissions
By the dates listed in section III. A of this document, all
manufactures currently marketing preamendments class III devices
subject to this order shall provide a summary of, and citation to, any
information known or otherwise available to them respecting the
devices, including adverse safety and effectiveness data which has not
been submitted under section 519 of the act. FDA suggests that it may
be in the best interest of submitters to summarize the information
submitted under section 519 of the act to facilitate FDA's
decisionmaking, even though such information is not required.
The information should be submitted in one of the two following
formats depending on whether the applicant is aware of any information
that would support the reclassification of the device into class I
(general controls) or class II (special controls). Information that
would support the reclassification of the device must consist of
adequate, valid scientific evidence showing that general controls alone
(class I), or general controls and special controls (class II) will
provide a reasonable assurance of the safety and effectiveness of the
device.
For manufacturers who are not aware of any information that would
support the reclassification of their device into class I or class II,
the information provided should be submitted in the following format:
1. Indications for use. A general description of the disease or
condition to be diagnosed, treated, cured, mitigated, or prevented,
including a description of the patient population for which the device
is intended.
2. Device description. An explanation of how the device functions,
significant physical and performance characteristics of the device, and
basic scientific concepts that form the basis for the device.
3. Other device labeling. Other device labeling that includes
contraindications, warnings and precautions and/or promotional
materials.
4. Risks. A summary of all adverse safety and effectiveness
information and identification of the risks presented by the device as
well as any mechanisms or procedures which will control the risk.
5. Alternative practices and procedures. A description of
alternative practices or procedures for diagnosing, treating,
preventing, curing, or mitigating the disease or condition for which
the device is intended.
6. Summary of preclinical and clinical data. The summary of
preclinical and clinical data should include the conclusions drawn from
the studies which support the safety and effectiveness of the device as
well as special controls, if any, which address the adverse effects of
the device on health. The summary should include a
[[Page 32358]]
brief description of the objective of the studies, the experimental
design, how the data were collected and analyzed, and a brief
description of the results of the studies, whether positive, negative,
or inconclusive. The summary of the clinical study(ies) should also
include a discussion of the subject inclusion and exclusion criteria,
the study population, reasons for patient discontinuations, and results
of statistical analyses.
7. Bibliography. A copy of the key references, a brief summary of
the salient features of each key reference, and a brief discussion of
why the reference is relevant to an evaluation of the safety and
effectiveness evaluation of the device.
Manufacturers who are aware of information that would support the
reclassification of their device into class I or class II may either
submit information using the format described below or may submit a
formal reclassification petition, which should include the information
described below in addition to the information required under 21 CFR
860.123:
1. Identification. A brief narrative identification of the device.
This identification should be specific enough to distinguish a
particular device from a generic type of device. Where appropriate,
this identification should include a listing of the materials, and the
component parts, and a description of the intended use of the device.
2. Risks to health. An identification of the risks to health should
be provided. This section should summarize all adverse safety and
effectiveness information that has not been submitted under section 519
of the act, particularly the most significant. The mechanisms or
procedures which will control the risk should be described. A list of
the general hazards associated with the device and a bibliography with
copies of the referenced material should be provided.
3. Recommendation. A statement whether the manufacturer believes
the device should be reclassified into class I or class II.
4. Summary of reasons for recommendation. Each manufacturer should
include a summary of the reasons for requesting reclassification of its
device and an explanation of why it believes the device meets the
statutory criteria for reclassification into class I or class II. Each
manufacturer should also identify the special controls that it believes
would be sufficient to provide reasonable assurance of the safety and
effectiveness of its device if it believes the device should be
reclassified into class II.
5. Summary of valid scientific evidence on which the recommendation
is based. Manufacturers are advised that, when considering a formal
reclassification petition, FDA will rely only upon valid scientific
evidence to determine that there is reasonable assurance of the safety
and effectiveness of the device, if regulated by general controls alone
(class I) or by general controls and special controls (class II). Valid
scientific evidence consists of evidence from well-controlled
investigations, partially controlled studies, studies and objective
trials without matched controls, well-documented case histories
conducted by qualified experts, and reports of significant human
experience with a marketed device, from which it can fairly and
responsibly be concluded by qualified experts that there is reasonable
assurance of the safety and effectiveness of a device under its
conditions of use. The evidence required may vary according to the
characteristics of the device, its conditions of use, the existence and
adequacy of warnings and other restrictions, and the extent of
experience with its use. Isolated case reports, random experience,
reports lacking sufficient details to permit scientific evaluation, and
unsubstantiated opinions are not regarded as valid scientific evidence
to show safety or effectiveness (see Sec. 860.7(c)(2)).
According to Sec. 860.7(d)(1), there is reasonable assurance that a
device is safe when it can be determined, based upon valid scientific
evidence, that the probable benefits to health from use of the device
for its intended uses and conditions of use, when accompanied by
adequate directions and warnings against unsafe use, outweigh any
probable risks. The valid scientific evidence used to determine the
safety of a device shall adequately demonstrate the absence of
unreasonable risk of illness or injury associated with the use of the
device for its intended uses and conditions for use. Moreover, under
Sec. 860.7(e)(1), there is reasonable assurance that a device is
effective when it can be determined, based upon valid scientific
evidence, that in a significant portion of the target population, the
use of the device for its intended uses and conditions of use, when
accompanied by adequate directions for use and warnings against unsafe
use, will provide clinically significant results.
Manufacturers submitting a formal reclassification petition may
wish to request two petitions as examples of successful
reclassification petitions. Magnetic resonance imaging devices, Docket
Nos. 87P-0214/CP-1 through CP-13, and Nd:YAG Laser for posterior
capsulotomy devices, Docket No. 86P-0083, were both reclassified from
class III to class II subsequent to the submission of reclassification
petitions. Both petitions are available upon submission of a Freedom of
Information request to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20850.
IV. Submission of Required Information
The summary of, and citation to, any information required by the
act must be submitted by the dates listed above to the Document Mail
Center (address above).
Dated: June 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-15450 Filed 6-12-97; 8:45 am]
BILLING CODE 4160-01-F
