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Docket ID: [Docket No. FDA-2008-D-0186] (formerly Docket No. 2000D-1384)

NOTICE: NOTICES

ACTION: Guidance for Industry and Food and Drug Administration Staff:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability

DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of surgeons' and patient examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that medical gloves imported to the United States meet FDA's minimum acceptable quality criteria and do not have defects that could compromise their effectiveness and pose a health hazard to healthcare professionals and patients who rely on medical gloves for protection from blood and fluidborne pathogens.

SUMMARY: Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Availability,

SUPPLEMENTAL INFORMATION

Healthcare providers, professionals, and others use surgeons' and/ or patient examination gloves (medical gloves) as a barrier against the transmission of blood and fluidborne pathogens. Defects in medical gloves, such as holes, can compromise the effectiveness of the glove barrier integrity and pose a potentially significant hazard to the health of users as well as patients.

FDA's Center for Devices and Radiological Health (CDRH) is aware from its import records that some foreign manufacturers and shippers repeatedly attempt to import into the United States medical gloves that fail water leak testing and therefore do not meet the acceptable quality criteria defined in 21 CFR 800.20. To address this situation, FDA has devised a riskbased tiered process for placing medical gloves from identified manufacturers/shippers on an import alert, for releasing individual shipments, and for removing medical gloves from the identified manufacturers/shippers from the import alert and consequent potential detention without physical examination. The process involves three levels of import surveillance and detention that may be applied over a 24month import surveillance cycle.

This final guidance document supersedes the draft guidance entitled ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves,'' which was announced in the Federal Register of July 26, 2000 (65 FR 45991). The comment period closed on October 24, 2000.

We received a small number of comments, and FDA has made some changes to the final guidance document based on these comments. One comment indicated that the risk of detention is greater for ``high volume'' manufacturers because they have many shipments and many FDA analyses in a 24month period and therefore a greater cumulative risk of ``Type 1'' statistical sampling error resulting in some shipments failing analyses even though the shipments are acceptable. After analyzing the import data, FDA agrees that in theory such sampling errors are possible, although FDA believes that such errors are unlikely to affect most medical glove manufacturers because they appear to be producing medical gloves at a defect rate well below the acceptance criteria of the FDA test. Nevertheless, the revised document recognizes the opportunity for manufacturers to present evidence to FDA in support of a reconsideration of their listing on the import alert if they believe for any reason that this listing is inappropriate, including as a result of statistical sampling errors or because previous defective shipments were found during a previously concluded import surveillance cycle.

Another change in the final guidance is that the 24month surveillance period will start when a firm is placed on Level 1 rather than when a firm is removed from Level 1, as was proposed in the original draft guidance. This change is being implemented to simplify the process and provide a level playing field for ``lowvolume'' firms that export shipments of gloves to the United States less frequently than highvolume firms and therefore generally take a longer time to obtain a number of consecutive passing entries sufficient for removal from the import alert.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination 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 statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves,'' you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240276 3151 to receive a hard copy. Please use the document number 1141 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 deviceoriented 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 at http://www.regulations.gov. IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 35013520). The collections of information in 21 CFR part 820 have been approved under OMB control number 09100073.

The information collection recommendations included in this document as part of the strategy for addressing further shipments of medical gloves from manufacturers/shippers who repeatedly export defective medical gloves to the United States do not require OMB clearance under the PRA. These collections of information are excepted from the requirements of the PRA under 5 CFR 1320.4(a)(2) and (c). The guidance recommends information to be collected and submitted to FDA ``during the conduct of an administrative action, investigation, or audit involving the agency against specific individuals'' (5 CFR 1320.4(a)(2)) and ``after a case file or equivalent is opened with respect to a particular party'' (5 CFR 1320.4(c)) in order for that specific party to rebut the appearance of adulteration and consequently obtain release of a particular shipment of its medical gloves or removal of its medical gloves from listing on import alert. [[Page 39972]]

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 Governmentwide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

Dated: July 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E815766 Filed 71008; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Diane Goldsberry, Center for Devices and Radiological Health (HFZ333), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 2402760115.