[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14282-14283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr07-49]
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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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of the draft guidance entitled ``Modifications to Devices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 This draft guidance is intended to help the regulated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This draft guidance is not final nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Modifications to Devices Subject to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 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
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