[Federal Register Volume 64, Number 87 (Thursday, May 6, 1999)]
[Notices]
[Pages 24408-24409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0024]


Immunotoxicity Testing Guidance; 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 ``Immunotoxicity Testing 
Guidance.'' This guidance is intended to provide FDA reviewers and 
manufacturers with a coherent strategy for assessing whether testing 
for potential adverse effects involving medical devices or constituent 
materials and the immune system is needed. The guidance is also 
intended to aid in developing a systematic approach to such testing.

DATES:  Written comments may be submitted at any time.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Immunotoxicity Testing Guidance'' 
to the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health (CDRH), 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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments on the ``Immunotoxicity Testing Guidance'' 
to the contact person listed below.

FOR FURTHER INFORMATION CONTACT: John J. Langone, Center for Devices 
and Radiological Health (HFZ-113), Food and Drug Administration, 12709 
Twinbrook Pkwy., Rockville, MD 20852, 301-443-2911.

SUPPLEMENTARY INFORMATION:

I. Background

    In May 1995, FDA adopted the General Program Memorandum G95-1, an 
FDA-modified version of International Standard ISO-10993, entitled 
``Biological Evaluation of Medical Devices--Part 1: Evaluation and 
Testing.'' It was pointed out that in addition to the general guidance 
for toxicity testing contained in that document, additional guidance 
might be needed for evaluation of specific organ or system toxicity. As 
a result, the Office of Device Evaluation, CDRH, developed the 
``Immunotoxicity Testing Guidance'' to deal specifically with testing 
for adverse effects of medical devices or constituent materials on the 
immune system. The guidance is intended to ensure a consistent and 
scientifically sound approach to the overall evaluation of product 
safety.
     In addition to explanatory text, the guidance contains: (1) A 
flowchart to determine if immunotoxicity testing is recommended, and 
(2) three tables that lead sequentially from potential immunological 
effects, to potential responses commonly associated with

[[Page 24409]]

those effects, to examples of testing that might be considered as part 
of the overall safety evaluation of finished devices or constituent 
materials.
     FDA published a notice of availability of the original draft 
guidance in the Federal Register of March 18, 1997 (62 FR 12832). 
Comments were received from 28 respondents, including medical device 
manufacturers, industry trade groups, and individuals. These comments 
were reviewed by the CDRH Immunotoxicology Working Group. Based on 
these comments, the draft guidance was revised to include additional 
didactic and technical information. The revised draft guidance was 
reviewed by a group of regulatory reviewers as well as senior CDRH 
management to obtain the final version of ``Immunotoxicity Testing 
Guidance.''

 II. Significance of Guidance

    This guidance represents the agency's current thinking on 
immunotoxicity testing of medical devices and constituents. 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 is issued as a Level 1 guidance consistent with 
GGP's.

III. Electronic Access

    In order to receive ``Immunotoxicity Testing Guidance'' via your 
fax machine, call the CDRH Facts-On-Demand 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 (635) 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 World Wide Web (WWW). CDRH maintains an entry on the WWW 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the WWW. 
Updated on a regular basis, the CDRH home page includes 
``Immunotoxicity Testing Guidance,'' 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''. The ``Immunotoxicity Testing Guidance'' document 
will be available at ``http://www.fda.gov/cdrh/ost/ostggp/
immunotox.html''.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding this guidance to the contact person listed previously. Such 
comments will be considered when determining whether to amend the 
current guidance.

    Dated: April 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-11345 Filed 5-5-99; 8:45 am]
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