[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Notices]
[Pages 45991-45992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18830]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1384]


Medical Devices; Draft Guidance for Surveillance and Detention 
Without Physical Examination of Surgeons' and/or Patient Examination 
Gloves; 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availability of a draft guidance entitled ``Guidance for Surveillance 
and Detention Without Physical Examination of Surgeons' and/or Patient 
Examination Gloves.'' Many foreign manufacturers and shippers of 
surgeons' and/or patient examination gloves have consistently failed to 
provide surgeons' and/or patient examination gloves of adequate quality 
for distribution in the United States, which presents a potential 
serious hazard to health for users and patients. The draft guidance is 
intended to help industry understand our policy to monitor continuously 
recidivist firms under our import program. This policy is neither final 
nor is it in effect at this time.

DATES: Submit written comments concerning this draft guidance by 
October 24, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Draft Guidance for Surveillance and 
Detention Without Physical Examination of Surgeons' and/or Patient 
Examination Gloves'' to the Division of Small Manufacturers Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label 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 
guidance.
    Submit written comments concerning this guidance to the Dockets 
Management Branch, (HFA-305), Food

[[Page 45992]]

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Comments should be identified with the docket number found in 
the brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Rebecca K. Keenan, Center for Devices 
and Radiological Health (HFZ-333), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4618.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to provide guidance to FDA staff 
and industry about a recidivist policy for firms that repeatedly 
attempt to import surgeons' and patient exam gloves that violate 
quality requirements. FDA's experience with sampling, examination, and 
testing of surgeons' and/or patient examination gloves raises concerns 
about the barrier properties of some gloves exported to the United 
States. Our analyses of surgeons' and patient examination gloves 
exported to the United States show a significant variation in the 
quality of the gloves exported by various manufacturers/shippers. We 
repeatedly place the same manufacturers/shippers on import detention 
due to leaks and defects in their gloves. These firms then need to 
provide us with private laboratory analyses for a number of shipments 
in order to demonstrate that the quality of the gloves and the firm's 
manufacturing operations comply with FDA standards. Once the firms 
provide such evidence, we remove them from import alert. However, many 
of these same manufacturers/shippers have repeated violative analyses 
and return to import alert status. This cyclical problem of violations 
requires continuous auditing and monitoring of recidivist firms to 
prevent the entry of defective gloves into the United States.
    In an attempt to ensure that surgeons' and/or patient examination 
gloves exported to the United States are in compliance with FDA's 
standards, we revised Import Alert #80-04, ``Surveillance and Detention 
Without Physical Examination of Surgeons' and/or Patient Examination 
Gloves,'' referred to as the ``recidivist policy.'' This initiative was 
a joint effort between the agency's Center for Devices and Radiological 
Health's Office of Compliance, ORA's Division of Import Operations and 
Policy, and the Office of Chief Counsel.
    The recidivist policy defines three increasingly stringent 
compliance levels for firms who have shipped violative surgeons' and 
patient examination gloves to the United States. Levels 1 and 2 allow 
voluntary compliance opportunities, while Level 3 provides a mechanism 
to issue a warning letter for apparent violations of the Federal Food, 
Drug, and Cosmetic Act, including noncompliance with the quality 
systems regulation for good manufacturing practices. A finding of Level 
3 noncompliance will automatically place any future shipments of 
surgeons' or patient examination gloves from the manufacturer/shipper 
on detention, without the need for FDA to perform an actual inspection 
at the manufacturer, due to the continued failure of the surgeons' and/
or patient examination gloves to pass minimum FDA standards upon 
import.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a draft Level 1 guidance 
consistent with GGP's. This guidance document represents the agency's 
current thinking on the 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 applicable statute, regulations, or both.

II. Electronic Access

    In order to receive the draft guidance on ``Guidance for 
Surveillance and Detention Without Physical Examination of Surgeons' 
and/or Patient Examination Gloves'' via your fax machine, call the CDRH 
Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. At the first voice prompt press 1 to access DSMA 
Facts, at second voice prompt press 2, and then enter the document 
number 1141 followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. 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 access to the Internet. Updated 
on a regular basis, the CDRH home page includes various Level 1 
guidance documents for comment, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Guidance for Surveillance and Detention Without Physical 
Examination of Surgeons' and/or Patient Examination Gloves'' will be 
available at http://www.fda.gov/cdrh/oc/glove1.pdf.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
October 24, 2000. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The draft guidance document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 12, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-18830 Filed 7-25-00; 8:45 am]
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