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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