[Federal Register: February 23, 1995 (Volume 60, Number 36)]
[Notices], [Page 10087-10088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23fe95-73]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88N-0319]

-----------------------------------------------------------------------

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

Posted by Office of Special Health Issues, HF-12