[Federal Register Volume 72, Number 58 (Tuesday, March 27, 2007)]
[Notices]
[Pages 14282-14283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5572]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0083]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Modifications to Devices Subject to Premarket Approval--The 
Premarket Approval Supplement Decision-Making Process; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Modifications to Devices 
Subject to Premarket Approval (PMA)--The PMA Supplement Decision-Making 
Process.'' This draft guidance is intended to help the regulated 
industry determine whether submitting a PMA supplement or other 
notification to FDA is required for class III devices subject to PMA. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
June 25, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Modifications to Devices Subject to 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, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 240-276-3151. 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.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For general questions: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010.
    For questions about the 30-day notice program or regarding 
manufacturing site changes: Christy Foreman, Center for Devices and 
Radiological Health (HFZ-340), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0120.
    For biologics issues: Leonard Wilson, Center for Biologics 
Evaluation and Research (HFM-25), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to help the regulated industry 
determine whether submitting a PMA supplement or other notification to 
FDA is required for class III devices subject to PMA. FDA developed 
this draft guidance to address modifications 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. This draft guidance 
is intended to apply to the device portion of combination products such 
as drug/device or biologic/device combinations.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on 
modifications to devices subject to PMA applications. 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 draft 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 [email protected] 
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 
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 Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA). 
The collections of information addressed in the draft guidance document 
have been approved by OMB in accordance with the PRA under the 
regulations governing PMA applications (21 CFR part 814, OMB control 
number 0910-0231).

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

[[Page 14283]]

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.

    Dated: March 16, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-5572 Filed 3-26-07; 8:45 am]
BILLING CODE 4160-01-S