Document ID: FDA-2000-D-0186-0002
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons and/or Patient Examination Gloves; Availability
Posted Date: 2008-07-11T04:00Z

[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Notices]               
[Page 39970-39972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy08-53]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Guidance for Industry and Food and Drug Administration Staff; 
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 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 fluid-borne pathogens.

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

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Surveillance and Detention Without Physical 
Examination of Surgeons' and/or Patient Examination Gloves'' 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

[[Page 39971]]

one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Diane Goldsberry, Center for Devices 
and Radiological Health (HFZ-333), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0115.

SUPPLEMENTARY INFORMATION:

I. Background

    Healthcare providers, professionals, and others use surgeons' and/
or patient examination gloves (medical gloves) as a barrier against the 
transmission of blood- and fluid-borne 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 risk-based 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 24-month 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 24-month 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 24-month 
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 ``low-volume'' firms 
that export shipments of gloves to the United States less frequently 
than high-volume 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 e-mail request to dsmica@fda.hhs.gov to receive 
an electronic copy of the document or send a fax request to 240-276-
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 device-oriented 
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. 3501-3520). 
The collections of information in 21 CFR part 820 have been approved 
under OMB control number 0910-0073.
    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 Government-wide, 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. E8-15766 Filed 7-10-08; 8:45 am]

BILLING CODE 4160-01-S