[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75724-75725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0611]
Draft Guidance for Industry and Food and Drug Administration
Staff; Submission and Review of Sterility Information in Premarket
Notification Submissions for Devices Labeled as Sterile; 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availability of the draft guidance entitled ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile.'' This draft guidance document updates
and clarifies the procedures for reviewing premarket notification
submissions (510(k)s) for devices labeled as sterile, particularly with
respect to sterilization technologies FDA considers novel, and the
information that should be included in 510(k)s for devices labeled as
sterile.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 12, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile'' to the Division of Small Manufacturers,
International, and
[[Page 75725]]
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 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 draft 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:
Steven Turtil, Center for Devices and Radiological Health (HFZ-
480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-3747;
Chiu Lin, Center for Devices and Radiological Health (HFZ-480),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-3700; or
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 document updates and clarifies the procedures
for reviewing premarket notification submissions (510(k)s) for devices
labeled as sterile, particularly with respect to sterilization
technologies FDA considers novel. The draft guidance provides details
about the pyrogenicity information we recommend be included in 510(k)s
for devices labeled as sterile. When final, this draft will supersede
the guidance entitled ``Updated 510(k) Sterility Review Guidance K90-
1'' that FDA issued on August 30, 2002 (available at http://www.fda.gov/cdrh/ode/guidance/361.pdf).
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 premarket
notification submissions for devices labeled as sterile. 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 ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile,'' 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 1615 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 CBER Internet site at http://www.fda.gov/cber/guidelines.htm or the Division of Dockets Management Internet site at
http://www.regulations.gov.
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 (the PRA) (44 U.S.C. 3501-
3520). This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA. The collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.
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 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29413 Filed 12-11-08; 8:45 am]
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