Document ID: FDA-2008-D-0611-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled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
Posted Date: 2008-12-12T05:00Z

[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Notices]               
[Page 75724-75725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de08-82]                         

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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Submission and Review of 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 This draft guidance document updates 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Submission and Review of Sterility 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 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 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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