[Federal Register Volume 59, Number 87 (Friday, May 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10998]
[[Page Unknown]]
[Federal Register: May 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
[Docket No. 94N-0118]
Preamendments Class III Devices; Strategy Document; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is making available a
document that sets forth the agency's strategy for implementing the
provisions of the Safe Medical Devices Act of 1990 (the SMDA) which
require FDA to review the classification of certain class III
(premarket approval) devices, and either reclassify the devices into
class I (general controls) or class II (special controls) or retain
them in class III. The statute also requires FDA to establish a
schedule for requiring the submission of premarket approval
applications (PMA's) for those devices retained in class III.
DATES: Written comments by August 4, 1994.
ADDRESSES: Submit written requests for single copies of the strategy
document to the Division of Small Manufacturers Assistance (HFZ-200),
Center for Devices and Radiological Health, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your
requests. Submit written comments on the strategy document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document. The strategy document and received comments
are available for public examination in the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-4765, ext. 157.
SUPPLEMENTARY INFORMATION: 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. 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. Similarly, a
preamendments device 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 submission of a PMA for
the device. To date, FDA has issued eight final rules requiring
submission of PMA's for preamendments class III devices. Nine
additional proposed rules have been issued.
The SMDA (Pub. L. 101-629) added new section 515(i) to the act (21
U.S.C. 360e(i)). This section requires FDA to order manufacturers of
class III preamendments devices for which no final rule has been issued
requiring the submission of PMA's to submit to FDA a summary of, and
citation to, any information known or otherwise available to the
manufacturer respecting such devices, including adverse safety and
effectiveness information that has not been submitted under section 519
of the act (21 U.S.C. 360i). Section 515(i) of the act further 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 retaining the device in class III.
Within 12 months after publication of a regulation retaining a device
in class III, the statute requires FDA to establish a schedule for the
promulgation of a rule requiring the submission of PMA's for the
device. 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 procedure
in section 515(i) of the act.
Since enactment of the SMDA, FDA has issued proposed rules to
require the submission of PMA's for five devices: Silicone inflatable
saline filled breast prostheses; penile implants; testicular implants;
nonroller cardiovascular blood pumps; and cranial electrotherapy
stimulators. FDA is now announcing the availability of a document
outlining its plans for either revising the classification, or
requiring the submission of PMA's for the remaining preamendments class
III devices.
FDA has divided this universe of devices into three groups:
1. Group 3 devices are devices that FDA believes are currently in
commercial distribution and are not likely candidates for
reclassification. FDA will require the submission of PMA's for these
devices in the near future. FDA intends to issue proposed rules to
require the submission of PMA's for the 15 highest priority devices in
this group in phases over the next 3 years. In accordance with the
procedures in section 515(b) of the act, manufacturers will have an
opportunity to petition for reclassification of these devices by
submitting a reclassification petition within 15 days of publication of
the proposed rule to require submission of PMA's. Manufacturers who
wish to petition for reclassification should begin preparing petitions
for reclassification as soon as possible. FDA will initiate the 515(i)
process for the remaining Group 3 devices.
2. Group 2 devices are devices that FDA believes have a high
potential for being reclassified into class II. For these devices, FDA
intends to issue an order under section 515(i) of the act requiring
manufacturers to submit a summary of, and citation to, any information
respecting these devices. A manufacturer who wishes to have one of
these devices reclassified will be required to submit information to
support reclassification of the device.
3. 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 believes that, for these devices, rulemaking
under section 515(b) of the act will not result in viable PMA's or
reclassification petitions. FDA intends to initiate a rulemaking
proceeding to require the submission of PMA's for this group of
devices. FDA will review any information received in response to the
proposed rule to determine whether to issue a final rule requiring the
submission of PMA's.
The strategy document lists the devices by categories in each of
these groups. It also describes in more detail FDA's plans for
implementing these procedures.
FDA believes that the procedures set forth in this strategy
document are consistent with the congressional intent in enacting
section 515(i) of the act. The Senate report makes clear the need to
require submission of PMA's as soon as possible for those devices that
are to remain in class III. (See S. Rept. 513, 101st Cong., 2d sess. 18
(1990)). Furthermore, the House of Representatives Report of the Safe
Medical Devices Act of 1990 stated:
In formulating these schedules [for requiring the submission of
a PMA], the FDA should take into account its priorities and limited
resources, together with the Committee's intention that the
evaluation process be expeditious.
(See H. Rept. 808, 101st Cong., 2d sess. 26 (1990)).
Interested persons may, on or before July 9, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this strategy document. 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. The strategy document and received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 3, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-10998 Filed 5-5-94; 8:45 am]
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