[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Notices]
[Pages 41984-41986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19944]
[[Page 41983]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
Order for Certain Class III Devices; Submission of Safety and
Effectiveness Information; Notices
Federal Register / Vol. 60, No. 156 / Monday, August 14, 1995 /
Notices
=======================================================================
-----------------------------------------------------------------------
[[Page 41984]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0418]
Order for Certain Class III Devices; Submission of Safety and
Effectiveness Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
requiring manufacturers of 27 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 27 devices are not likely
candidates for reclassification and, therefore, will likely require the
submission of PMA's sometime in the future.
DATES: Summaries and citations must be submitted by the dates listed
below.
ADDRESSES: Submit summaries and citations to the Documents Mail Center
(HFZ-401), Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
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 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 21 CFR part 812 until the date stipulated by FDA in the final rule
requiring the submission of a PMA 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 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 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
[[Page 41985]]
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 27 devices in
Group 3 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, based on information known to date by the agency, FDA
believes these devices are not likely candidate for reclassification.
Elsewhere in this issue of the Federal Register, FDA is publishing
a similar notice covering the 31 Group 2 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
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 nine devices, the required information shall be
submitted by August 14, 1996.
1. Sec. 868.2450 Lung water monitor.
2. Sec. 868.2500 Cutaneous oxygen monitor.
3. Sec. 868.5610 Membrane lung for long-term pulmonary support.
4. Sec. 870.1025 Arrhythmia detector and alarm.
5. Sec. 870.3300 Arterial embolization device.
6. Sec. 870.3375 Cardiovascular intravascular filter.
7. Sec. 874.3400 Tinnitus masker.
8. Sec. 884.5940 Powered vaginal muscle stimulator for therapeutic
use.
9. Sec. 890.3890 Stair-climbing wheelchair.
For the following nine devices, the required information shall be
submitted by February 14, 1997.
10. Sec. 870.3610 Implantable pacemaker pulse generator.
11. Sec. 870.3700 Pacemaker programmers.
12. Sec. 870.3800 Annuloplasty ring.
13. Sec. 870.4230 Cardiopulmonary bypass defoamer.
14. Sec. 870.5225 External counter-pulsating device.
15. Sec. 870.5550 External transcutaneous cardiac pacemaker
(noninvasive).
16. Sec. 874.3930 Tympanostomy tube with semipermeable membrane.
17. Sec. 874.5350 Suction antichoke device.
18. Sec. 886.3400 Keratoprosthesis.
For the following nine devices, the required information shall be
submitted by August 14, 1997.
19. Sec. 870.3450 Vascular graft prosthesis of less than 6
millimeters diameter.
20. Sec. 870.3535 Intra-aortic balloon and control system.
21. Sec. 870.3600 External pacemaker pulse generator.
22. Sec. A874.5370 Tongs antichoke device.
23. Sec. 876.5870 Sorbent hemoperfusion system.
24. Sec. 876.5955 Peritoneo-venous shunt.
25. Sec. 882.1790 Ocular plethysmograph.
26. Sec. 882.5860 Implanted neuromuscular stimulator.
27. Sec. 882.5950 Artificial embolization 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 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
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
[[Page 41986]]
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.
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 a 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. 95-19944 Filed 8-11-95; 8:45 am]
BILLING CODE 4160-01-F