2011-12037. Compliance Policy Guide: Surgeons' Gloves and Patient Examination Gloves; Defects-Criteria for Direct Reference Seizure

AGENCY:

Food and Drug Administration, HHS.

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.