[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