[Federal Register Volume 60, Number 36 (Thursday, February 23, 1995)]
[Notices]
[Pages 10087-10088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4465]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88N-0319]
Home Specimen Collection Kit Systems Intended for Human
Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions
to Previous Guidance
Agency: Food and Drug Administration, HHS.
Action: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is revising its
previous guidance for the approval of home specimen collection kit
systems intended for the detection of antibodies to Human
Immunodeficiency Virus type 1 (HIV-1), that was published in the
Federal Register of February 17, 1989, and July 30, 1990.
DATES: Submit written comments by April 10, 1995.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary Gustafson, Center for Biologics
Evaluation and Research (HFM-370), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-2012.
SUPPLEMENTARY INFORMATION:
I. Background
FDA announced in the Federal Register of February 17, 1989 (54 FR
7279), the scheduling of an open public meeting and invited written
comments on blood collection kits and home test kits designed to detect
HIV-1 antibody. The document listed five factors that the agency was
applying to the review of applications for premarket approval of blood
collection kits labeled for HIV-1 antibody testing. At that time, FDA
believed that blood collection kits labeled for HIV-related testing
should be restricted to professional use in a health care environment.
On April 6, 1989, FDA held an open public meeting to obtain comments on
the issues related to applications for premarket approval of blood
collection kits labeled for HIV-1 antibody testing. Comments also were
solicited on kits for home collection and home testing of blood for
evidence of HIV-1 infection.
In the Federal Register of July 30, 1990 (55 FR 30982), FDA
announced the availability of a letter to firms and individuals who
previously had asked FDA about the potential marketing of blood
collection kits labeled for HIV-1 testing. In that document, which
included the full text of the letter, FDA indicated its willingness to
accept investigational device exemptions (IDE's) and to review
applications for blood collection kits for HIV-1 testing intended for
home use, but did not revise the list of factors, previously set forth
in the February 17, 1989, Federal Register (54 FR 7279) document, that
the agency would consider in evaluating the safety and effectiveness of
specimen collection kits.
In light of scientific and technological developments and the
changing nature of the HIV epidemic, FDA announced in the Federal
Register of June 9, 1994 (59 FR 29814), that the agenda for FDA's Blood
Products Advisory Committee meeting, scheduled for June 21 and 22,
1994, would include a discussion of issues related to home specimen
collection kits labeled for HIV antibody testing, and that the
discussion would reexamine FDA's approach to evaluating the safety and
effectiveness of such kits. More than 60 members of the public,
including potential product sponsors, academicians, physicians, clergy,
HIV counselors, and representatives of various interest groups, made
public presentations before the Blood Products Advisory Committee prior
to the committee's discussion of these issues. Most of the advisory
committee members believed that the potential benefits of over-the-
counter (OTC) home specimen collection kits outweighed the potential
risks.
II. The Revision
In this document, FDA is revising the previous guidance for blood
sample collection kits labeled for HIV antibody testing set forth in
the February 17, 1989, Federal Register document and in the July 30,
1990, Federal Register document. This revised guidance addresses only
OTC products intended for the home collection of specimens (including
blood and non-blood based specimens) for HIV antibody testing
(including HIV-1 and/or HIV-2), and supersedes prior guidance about
such home specimen collection kits. This revised guidance does not
address professional use specimen collection kits for HIV testing or
kits for home testing of specimens for evidence of HIV infection.
After significant consideration, including discussion at two public
meetings, FDA has concluded that OTC home specimen collection kit
system for HIV testing may be approvable. Each premarket approval
application (PMA) for an OTC home specimen collection kit system
labeled for HIV-1 and/or HIV-2 antibody testing will be evaluated for
safety and effectiveness based on the proposed intended use. In
general, sponsors should include information on the following points:
(1) Appropriate preclinical studies and clinical trials conducted
under an approved IDE should validate all technical aspects of the home
specimen collection and testing system and demonstrate the
reproducibility, sensitivity, and specificity of test results in
comparison with an approved, professional use system for the collection
and testing of blood or any other appropriately validated specimen.
Field trials should be conducted in a population likely to resemble the
intended market for the collection kit. Lay comprehension of the
instructions and educational materials, the ability of individual
consumers to accurately identify whether the test is applicable to
them, adequacy of home collection and shipment of the specimen by
consumers, the adequacy of pretest and post-test counseling, and the
ability of consumers to take appropriate followup action when indicated
should be addressed. Safe handling and transport of the specimen and
safe disposal of potentially hazardous materials also should be
demonstrated. Sponsors additionally should document adequate quality
assurance related to product manufacture, testing of the specimen
(including laboratory proficiency controls) in a laboratory that is in
compliance with the Clinical Laboratories Improvement Act of 1988
(CLIA), maintenance of test records, and a system for reporting of
adverse events or device failures.
(2) The testing for all specimens collected using the home specimen
collection kits should include the use of [[Page 10088]] a licensed
screening test for HIV-1 and/or HIV-2 antibodies and, for those
specimens testing repeatedly reactive by the screening test, the use of
a licensed, more specific test (e.g., Western blot, immunofluorescence
assay, or comparable test). Both the screening and confirmatory tests
should be validated and labeled for use on the particular home specimen
collection kit system specimens.
(3) Results of testing should be reported to test subjects by
persons appropriately trained in HIV notification and counseling.
Counseling of persons with confirmed positive test results should
include referral to medical and social support services in the area
where the person lives.
(4) The sponsor should also consider the gathering and reporting of
demographic data as appropriate. In addition, the sponsor should
discuss proposals for appropriate postmarketing studies to assess the
public health impact of OTC home specimen collection kit systems for
HIV testing.
FDA approval of a PMA would be based upon a finding that
information and data submitted in the PMA demonstrate the safety and
effectiveness of the home specimen collection kit system (including
counseling), and that facility inspections (including any dedicated
testing and counseling sites) demonstrate compliance with current good
manufacturing practices for medical devices.
This document represents current agency guidance on OTC products
intended for the home collection of specimens (including blood and non-
blood based specimens) for HIV antibody testing. Other guidance may be
developed over time in response to developing technology, public health
concerns, consumer preferences, and product submissions.
A manufacturer who wishes to pursue the marketing of a home
specimen collection kit system for HIV-1 and/or HIV-2 antibody testing
is invited to consult with FDA about the information that should be
included in the IDE and PMA submissions. For further information
contact Mary Gustafson, Director, Division of Blood Applications,
Center for Biologics Evaluation and Research, FDA, at 301-594-2012.
III. Request for Comments
Interested persons may, on or before April 10, 1995, submit to the
Dockets Management Branch (address above) written comments regarding
the modifications to this 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. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 15, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-4465 Filed 2-22-95; 8:45 am]
BILLING CODE 4160-01-F