
[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Rules and Regulations]
[Pages 28308-28309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12037]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. FDA-2011-D-0258]


Compliance Policy Guide: Surgeons' Gloves and Patient Examination 
Gloves; Defects--Criteria for Direct Reference Seizure

AGENCY: Food and Drug Administration, HHS.

[[Page 28309]]


ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of Compliance Policy Guide Sec. 335.700, Surgeons' Gloves 
and Patient Examination Gloves; Defects--Criteria for Direct Reference 
Seizure (the CPG). The CPG, which was originally issued in 1991, 
provides guidance to FDA staff on the submission of seizure 
recommendations for medical gloves that exceed the defect levels in FDA 
regulations. The CPG has been revised to remove an appendix that became 
obsolete when the regulations were amended, and to make other minor 
changes for clarity and consistency with the amended regulation.

DATES: Submit either electronic or written comments on the CPG at any 
time.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
one self-addressed adhesive label to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the CPG.
    Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments on the CPG to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David R. Kalins, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-6612.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient 
Examination Gloves; Defects--Criteria for Direct Reference Seizure.'' 
The CPG provides guidance to FDA staff on the submission of seizure 
recommendations for medical gloves that exceed the defect levels in 21 
CFR 800.20. The CPG was originally issued on May 31, 1991, and was 
previously revised in July 2005. It is currently being revised to 
remove an appendix that became obsolete when an amendment to 21 CFR 
800.20 became effective December 19, 2008. The amended rule includes 
changes intended to improve the barrier quality of medical gloves 
marketed in the United States by reducing the acceptable quality levels 
(AQLs) for leaks and visual defects observed during FDA testing of 
medical gloves. The CPG was revised for consistency with the AQLs in 
the amended regulation. The text of the CPG also includes a number of 
minor edits made for clarity. This document supersedes Compliance 
Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination 
Gloves; Defects--Criteria for Direct Reference Seizure dated July 2005.
    FDA is issuing the CPG as Level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The CPG represents 
FDA's current thinking on the criteria for direct reference seizure of 
defective medical gloves. 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
CPG. It is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed comments. Identify comments 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.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG at either 
http://www.fda.gov/ora/compliance_ref/cpg/default.htm or at http://www.regulations.gov.

    Dated: May 5, 2011.
Dara A. Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2011-12037 Filed 5-16-11; 8:45 am]
BILLING CODE 4160-01-P


