[Federal Register: May 15, 2003 (Volume 68, Number 94)]
[Page 26308-26309]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03D-0137]

Medical Devices: Draft Guidance for Industry and FDA; Surgical 
Masks--Premarket Notification Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry entitled ``Surgical 
Masks--Premarket Notification (510(k)) Submissions; Draft Guidance for 
Industry and FDA.'' This draft guidance is intended to assist industry 
in preparing premarket notification submissions for surgical masks. 
This draft guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
June 16, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance entitled ``Surgical Masks--Premarket 
Notification (510(k)) Submissions; Draft Guidance for Industry and 
FDA'' 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 two self-addressed adhesive labels to assist that office in 
processing your request or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance.
    Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.


I. Background

    FDA previously issued on its Web site a draft guidance entitled 
``Draft Guidance for Industry and FDA Reviewers on the Content and 
Format of Premarket Notification (510(k)) Submissions for Surgical 
Mask'' on January 16, 1998; however, no notice of availability was 
published in the Federal Register. We are seeking to correct that error 
by issuing the draft guidance again for comment with a notice of 
availability in the Federal

[[Page 26309]]

Register. FDA will consider the comments received and make every effort 
to issue the draft guidance for implementation in a reasonable time 
after the comment period has closed.
    We have also revised the draft guidance by adding information 
concerning industry's option to submit an abbreviated 510(k) and 
retitled the guidance for clarity.

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 surgical 
masks. 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. 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). The collections of information addressed in the draft guidance 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notification submissions (21 CFR part 
807, subpart E, OMB control number 0910-0120). The labeling provisions 
addressed in the draft guidance have been approved by OMB under the PRA 
under OMB control number 0910-0485.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Submit 
a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two paper copies of any mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

V. Electronic Access

    The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A 
search capability for all CDRH guidance documents are also available on 
the Dockets Management Branch Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
    To receive a copy of ``Surgical Masks--Premarket Notification 
(510(k)) Submissions; Draft Guidance for Industry and FDA'' by fax, 
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 
from a touch-tone telephone. Press 1 to enter the system. At the second 
voice prompt, press 1 to order a document. Enter the document number 
(094) followed by the pound sign ([numsign]). Follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains a site 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.

    Dated: May 5, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-12193 Filed 5-14-03; 8:45 am]