[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Notices]
[Pages 41986-41989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19945]
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[Docket No. 94N-0417]
Order for Certain Class III Devices; Submission of Safety and
Effectiveness Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
requiring manufacturers of 31 class III devices 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 which has not been
submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA
is requesting this information in order to determine, for each device,
whether the classification of the device should be revised, or whether
a regulation requiring the submission of premarket approval
applications (PMA's) for the device should be promulgated. Based on
preliminary information, FDA believes these 31 devices have a higher
potential for reclassification.
DATES: Summaries and citations must be submitted by the dates listed
below.
ADDRESSES: Submit summaries and citations to the Documents Mail Center
(HFZ-401), Food and Drug Administration, Center for Devices and
Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850.
[[Page 41987]]
FOR FURTHER INFORMATION CONTACT: Melpomeni K. Jeffries, 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 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. 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 ``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. However, submission of a
PMA, or a notice of completion of a product development protocol (PDP),
is not required until 90 days after FDA promulgates 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
of part 812 (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 nine preamendment class III devices. Additionally, FDA has
issued proposed rules for 10 other devices. There are 116 remaining
preamendment class III devices for which FDA has not yet initiated
action requiring the submission of PMA's.
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)), 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) (21 U.S.C. 360e(i)) to the
act. This section requires FDA to order manufacturers of preamendment
class III devices for which no final regulation has been issued
requiring the submission of PMA's 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 (21 U.S.C. 360i) 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
either revise the classification of the device into class I or class II
or require the device to remain in class III; and for devices remaining
in class III, 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 remaining preamendment class III
devices. In that notice, FDA made available a document setting forth
its strategy for implementing the provisions of the SMDA which require
FDA to review the classification of certain class III devices, and
either reclassify them into class I or class II or retain them in class
III. Pursuant to this plan, the agency divided the universe of
preamendment class III devices into the following 3 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. 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 intent to call for the
submission of PMA's for the 15 highest priority devices in Group 3 and
for all Group 1 devices. The agency also announced its intent to issue
an order under section 515(i) of the act for the remaining Group 3
devices and all of the Group 2 devices. 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.
Based upon the information submitted in response to this order, FDA
will either propose reclassification of some or all of these devices
into class I or class II, or propose retaining some or all of them in
class III.
In this document, FDA is requiring manufacturers of all 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 information concerning the
devices which has not been submitted under section 519 of the act. As
noted above, FDA believes that these devices have a higher potential
for reclassification provided that manufacturers collect, analyze, and
submit the necessary supporting information in response to this notice.
Elsewhere in this issue of the Federal Register, FDA is publishing
a similar notice with respect to the 27 remaining Group 3 devices.
II. Statutory Authority and Enforcement
In addition to the provisions of section 515(i) of the SMDA
described above, 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 furnish the information required by this order results
in the device being misbranded under section 502(t) of the act (21
U.S.C. 352 (t)) and is a prohibited act under sections 301(a) and (q)
of the act (21 U.S.C. 331(a) and (q)). The agency will use its
enforcement
[[Page 41988]]
powers to deter noncompliance. Violations of section 301 of the act may
be subject to seizure or injunction under sections 304(a) and 302(a) of
the act (21 U.S.C. 334(a) and 332(a) respectively). 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 (21 U.S.C.
333(a)).
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.
A. Deadlines for Submission of Information
For the following 8 devices, the required information shall 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 implant.
For the following 9 devices, the required information shall 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 10 devices, the required information shall be
submitted by August 14, 1997.
18. Sec. 868.1150 Indwelling blood carbon dioxide partial pressure
(Pco2) analyzer.
19. Sec. 868.1170 Indwelling blood hydrogen ion concentration (pH)
analyzer.
20. Sec. 868.1200 Indwelling blood oxygen partial pressure (Pco2)
analyzer.
21. Sec. 870.3680(b) Cardiovascular permanent pacemaker electrode.
22. Sec. 870.4260 Cardiopulmonary bypass arterial line blood
filter.
23. Sec. 870.4350 Cardiopulmonary bypass oxygenator.
24. Sec. 876.5860 High permeability hemodialysis system.
25. Sec. 878.5650 Topical oxygen chamber for extremities.
26. Sec. 882.5940 Electroconvulsive therapy device.
27. Sec. 888.3660 Shoulder joint metal/polymer semi-constrained
cemented prosthesis.
For the following 4 devices, the required information shall be
submitted by August 14, 1998.
28. Sec. 870.3710 Pacemaker repair or replacement material.
29. Sec. 870.4320 Cardiopulmonary bypass pulsatile flow generator.
30. Sec. 870.5200 External cardiac compressor.
31. Sec. 876.5540(b)(1) Implanted blood access device.
B. Required Contents of Submissions
By the dates listed above, all manufacturers 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 decision making, 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
which would support the reclassification of the device into class I
(general controls) or class II (special controls). Information which
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 do not believe that existing information
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 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 believe that existing information 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.
[[Page 41989]]
2. Risks to health. An identification of the risks to health should
be provided. This section should summarize all adverse safety and
effectiveness information, which have 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 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, pursuant
to 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 through 87P-0215/CP0013, 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
a reclassification petition. 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: July 13, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-19945 Filed 8-11-95; 8:45 am]
BILLING CODE 4160-01-F
