[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]
BILLING CODE 4160-01-F