[Federal Register Volume 64, Number 220 (Tuesday, November 16, 1999)]
[Notices]
[Pages 62208-62209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4487]
Medical Devices; Draft Guidance for Conducting Stability Testing
to Support an Expiration Date Labeling Claim for Medical 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availability of the draft guidance entitled ``Guidance for Conducting
Stability Testing to Support an Expiration Date Labeling Claim for
Medical Gloves.'' This guidance is neither final nor is it in effect at
this time. This guidance describes the information needed to support an
expiration date labeling claim for powdered or powder-free, surgeon's
or patient examination gloves. Expiration dating of medical gloves is
voluntary at this time. FDA recommends that manufacturers, repackagers,
or importers who add an expiration date labeling claim follow the
enclosed recommended criteria and protocols for conducting testing
described in this guidance.
DATES: Written comments concerning this draft guidance must be received
by February 14, 2000.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance. Submit written requests for
single copies on a 3.5'' diskette of the guidance document entitled,
``Guidance for Conducting Stability Testing to Support an Expiration
Date Labeling Claim for Medical 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 two self-addressed adhesive labels to assist that office in
processing your request, or fax your request to 301-443-8818. Written
comments concerning this guidance must be submitted to the Dockets
Management Branch, (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be
identified with the docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913.
SUPPLEMENTARY INFORMATION:
I. Background
It is estimated that millions of health care workers use medical
gloves on a daily basis as a barrier against blood borne pathogens and
microorganisms. The effective use of medical gloves as a barrier,
however, is dependent upon the integrity of the glove material.
Degradation of the glove material may occur when exposed to various
types of manufacturing processes (e.g., chlorination) and/or
environmental conditions.
In response to growing concerns regarding the use of natural rubber
latex (NRL), the National Institute of Occupational Safety and Health
recently issued a safety alert recommending the use of powder-free
medical gloves as a means to reduce exposure to natural
[[Page 62209]]
rubber latex allergens through the medical glove powder. With the
present shift in the medical glove market from powdered medical gloves
to powder-free, the potential for a rapid increase in the demand for
powder-free or nonpowdered gloves could result in products with poor
barrier integrity and/or unacceptable shelf-life. Processes to remove
glove powder such as chlorination have an adverse effect on various
mechanical and physical glove properties, which may affect shelf-life.
Expiration dating is not currently required for patient examination
or surgeon's gloves. However, FDA has just published a proposed
regulation to require expiration dating for all medical gloves (64 FR
41709, July 30, 1999). Currently, if manufacturers voluntarily label
their glove with an expiration date, they are expected to have real-
time data to support the shelf-life labeling claim. If real-time data
are not available, then a provisional shelf-life labeling claim, not to
exceed a period of 2 years, may be established based on accelerated
aging test data. This guidance provides recommended test methodology
and protocols for both real-time and accelerated aging that the
manufacturers may utilize to support an expiration date labeling claim.
Additionally, manufacturers of medical gloves may utilize this guidance
document to design process controls, as described in the quality system
regulation, for controlling manufacturing processes, such as
chlorination, to minimize adverse effects on glove barrier properties.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
conducting stability testing to support an expiration date labeling
claim for 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
applicable statute, regulations, or both.
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 Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive the ``Guidance for Conducting Stability Testing
to Support an Expiration Date Labeling Claim for Medical 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 (1355) 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. The Center for Devices and Radiological Health
(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 ``Guidance for Conducting
Stability Testing to Support an Expiration Date Labeling Claim for
Medical Gloves,'' 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 Conducting Stability Testing to Support an
Expiration Date Labeling Claim for Medical Gloves'' will be available
at http://www.fda.gov/cdrh.
IV. Comments
Interested persons may, on or before February 14, 2000, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. Such comments will be considered when
determining whether to amend the current guidance. 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 guidance document and
received comments may be seen in the Dockets Management Branch between
9 a.m. and 4 p.m., Monday through Friday.
Dated: October 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-29791 Filed 11-15-99; 8:45 am]
BILLING CODE 4160-01-F