[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Notices]
[Pages 27987-27988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0317]


Prompt Review of Supplemental Applications for Approved Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Devices 
and Radiological Health (CDRH) and Center for Biologics Evaluation and 
Research (CBER), in accordance with the FDA Modernization Act of 1997 
(FDAMA), are publishing standards for the prompt review of supplemental 
applications submitted for devices approved under the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.). Also, in 
accordance with FDAMA, CDRH and CBER are designating an individual 
within each center to be responsible for encouraging prompt review of 
supplements and for working with sponsors to facilitate development and 
submission of data to support such supplements.

DATES: Written comments by August 19, 1998.

ADDRESSES: Submit written comments concerning this notice to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:
    Robert M. Navazio, Center for Devices and Radiological Health (HFZ-
30), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 
20850, 301-594-1282, or
    Jerome A. Donlon, Center for Biologics Evaluation and Research 
(HFM-200), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-3028, 301-827-3028.

SUPPLEMENTARY INFORMATION:

I. Background

     FDAMA was enacted on November 21, 1997, in order to streamline the 
process of bringing safe and effective drugs, medical devices, and 
other therapies to the U.S. market. Section 403 of FDAMA addresses 
FDA's review of supplemental applications (``supplements'') submitted 
for articles approved under the act or section 351 of the Public Health 
Service Act.
    Section 403(a) of FDAMA requires FDA to publish in the Federal 
Register, not later than 180 days after enactment of FDAMA, standards 
for the prompt review of supplements. Section 403(b) requires FDA to 
issue final guidances by that same date to clarify the requirements 
for, and facilitate the submission of, data to support the approval of 
supplements. Section 403(b) also requires the guidance to clarify those 
circumstances in which published matter may be the basis for approval 
of supplements, to specify data requirements that will avoid 
duplication of previously submitted data, and to define those 
supplements that are eligible for priority review. Section 403(c) 
requires FDA to designate an individual within each center of FDA 
(except the Center for Food Safety and Applied Nutrition) to be 
responsible for encouraging prompt review of supplements and working 
with sponsors to facilitate development and submission of data to 
support supplements. Section 403(d) requires FDA to implement programs 
and policies that will foster collaboration between FDA, the National 
Institutes for Health, and others to identify studies that may support 
supplements and to encourage sponsors to submit and develop supplements 
based on such studies.
    In this notice, CDRH and CBER are publishing performance standards 
they have established for the prompt review of premarket approval 
application (PMA) supplements, in accordance with section 403(a) of 
FDAMA. Also, the Director, Office of Device Evaluation, CDRH, and the 
Deputy Director, Medical, CBER are designated as the individuals within 
each center who will be responsible for encouraging the prompt review 
of PMA supplements and working with sponsors to facilitate development 
and submission of data to support supplements, in accordance with 
section 403(c). Elsewhere in this issue of the Federal Register, CDRH 
is publishing a notice of availability of final guidance to industry to 
clarify the requirements for, and facilitate the submission of, data to 
support the approval of supplements, in accordance with section 403(b).

II. FDAMA Section 403(a)

    Following approval of a PMA or receipt of an order declaring a 
product development protocol (PDP) completed, the sponsor of the 
approved PMA or completed PDP must submit a supplement to the PMA or 
PDP for review and approval by FDA before making a change affecting the 
safety and effectiveness of the device, unless the device is of a type 
for which FDA has advised that an alternate submission is permitted.
    FDA measures its performance with respect to review of supplements 
by tracking and analysis of groups of incoming applications. These 
groups of submissions are referred to as Receipt Cohorts.

A. PDP Supplements

    In accordance with 21 CFR 814.19, a class III device for which a 
product development protocol has been declared completed by FDA will be 
considered to have an approved PMA. Accordingly, FDA intends to review 
PDP supplements in the same timeframe it reviews PMA supplements.
    FDA does not have baseline data for PDP supplements because no 
submissions of such supplements have been received. To the extent 
applicable, FDA intends to apply to PDP supplements the same 
performance standards described below for PMA supplements.

[[Page 27988]]

B. PMA Supplements

    In accordance with FDA regulations, PMA supplements ordinarily are 
required to be reviewed within 180 days (21 CFR 814.39(c)).
     The legislative history of section 403 of FDAMA indicates that 
Congress expected FDA to publish performance standards for those 
supplements submitted for changes in product use. Therefore, the data 
that follow do not reflect FDA performance standards for PMA 
supplements submitted for other changes, e.g., labeling or 
manufacturing. Historically, FDA has received approximately 300 to 500 
PMA supplements per year. Approximately 10 percent of these supplements 
address changes in the indication for use. Performance for the PMA 
supplement receipt cohort for changes in indication received during 
fiscal year (FY) 1996 and FY 97 was just over 70 percent completed 
within 180 days.
    Tracking for PMA supplements will continue to be accomplished using 
Receipt Cohorts as the basis for program performance. Projected 
performance for the FY 98 receipt cohort for changes in indication is 
expected to be 65 percent reviewed within 180 days. This estimate is 
based on making the best use of available FY 98 resources during a time 
of increasing workload attributable to implementation of FDAMA. In FY 
99, FDA will continue reengineering the device review process with 
emphasis on these new requirements. If adequate funding is provided, 
FDA expects that performance will be back to 70 percent in FY 99 and 
anticipates enhanced performance levels in subsequent years.

III. FDAMA Section 403(c)

    FDA has designated the following individuals within CDRH and CBER 
to work with sponsors to facilitate the development and submission of 
data to support supplemental applications for approved articles in 
accordance with section 403(c) of FDAMA:
    Director, Office of Device Evaluation, Center for Devices and 
Radiological Health (HFZ-400), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2022, and
    Deputy Director, Medical Center for Biologics Evaluation and 
Research (HFM-1), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-3028.

IV. Comments

    Interested persons may, on or before August 19, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. 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. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: May 18, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13721 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F