Document ID: FDA-2007-D-0025-0004
Agency: fda
Document Type: Notice
Title: Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process; Availability
Posted Date: 2008-12-11T05:00Z

[Federal Register: December 11, 2008 (Volume 73, Number 239)]
[Notices]               
[Page 75439-75440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de08-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0025] (formerly Docket No. 2007D-0083)

 
Guidance for Industry and the Food and Drug Administration; 
Modifications to Devices Subject to Premarket Approval--the Premarket 
Approval Supplement Decisionmaking Process; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Modifications to Devices 
Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making 
Process.'' The purpose of this guidance is to help industry determine 
the type of regulatory submission that may be required when a device 
subject to PMA is modified.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Modifications to Devices Subject to Premarket 
Approval (PMA)--the PMA Supplement Decision-Making Process,'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health (CDRH), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850; or to the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to CDRH at 240-276-3151. 
The guidance document may also be obtained by mail by calling CBER at 
1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010; or Stephen Ripley, 
Center for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA developed this guidance to address modifications to devices 
subject to PMA applications, including changes to device design, device 
labeling, and the device manufacturing process. This guidance also can 
be applied when a legally marketed class III device is the subject of a 
recall or field corrective action and the manufacturer needs to change 
the device to assure its safety and effectiveness.
    In the Federal Register of March 27, 2007 (72 FR 14282), FDA 
invited interested persons to comment on its draft guidance document 
entitled, ``Modifications to Devices Subject to Premarket Approval 
(PMA)--the PMA Supplement Decision-Making Process.'' The five general 
categories of comments received regarding the draft guidance are as 
follows: (1) Requests for a clearer interpretation of the regulations 
as to when a supplement is necessary (i.e., when a change to a device 
impacts or could impact safety and/or effectiveness); (2) requests for 
a detailed flowchart that would identify the type of supplement to be 
submitted based on any specific change for any device; (3) requests for 
specific definitions for some terms, such as ``substantial clinical 
data,'' ``significant change,'' and ``limited confirmatory clinical 
data;'' (4) requests for FDA to include 30-day supplements within the 
scope of the guidance; and (5) requests for additional examples for 
many supplement types, as well as for periodic reports. We considered 
all of the comments and revised the guidance when appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Modifications to Devices Subject to 
Premarket Approval (PMA)--the PMA Supplement Decision-Making Process.'' 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Modifications to Devices Subject to 
Premarket Approval (PMA)--the PMA Supplement Decision-Making Process,'' 
you may either send an e-mail request to dsmica@fda.hhs.gov to receive 
an electronic copy of the document or send a fax request to 240-276-
3151 to receive a hard copy. Please use the document number (1584) to 
identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small

[[Page 75440]]

manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the CBER Internet site at http://www.fda.gov/cber/
guidelines.htm or on the Division of Dockets Management Internet site 
at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The information collection provisions in 21 CFR part 814, 
subpart B (Premarket Approval Applications (PMAs)) in this guidance 
have been approved under OMB control number 0910-0231. This approval 
expires November 30, 2010.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29330 Filed 12-11-08; 8:45 am]

BILLING CODE 4160-01-S