[Federal Register Volume 62, Number 52 (Tuesday, March 18, 1997)]
[Notices]
[Pages 12832-12833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97D-0024]


Medical Devices; Immunotoxicity Testing Framework; Draft 
Guidance; Availability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availability of a draft guidance entitled ``Immunotoxicity Testing 
Framework.'' This guidance will provide 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 The draft guidance will also aid in 
developing a systematic approach to such testing.

DATES: Written comments by June 16, 1997.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Immunotoxicity Testing Framework'' to the Division 
of Small Manufacturers Assistance, Center for Devices and Radiological 
Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-0806 (toll free outside of MD 1-800-638-
2041). Send two self addressed adhesive labels to assist that office in 
processing your requests. The draft guidance is also available via the 
World Wide Web at http://www.fda.gov/cdrh/draftgui.html. A text only 
version is also available from a VT-100 compatible terminal via the FDA 
bulletin board by dialing 800-222-0185 (terminal settings are 8/1/N).

    Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville MD 20857. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.
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, 301-443-7132.

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, Center for Devices and 
Radiological Health, developed the

[[Page 12833]]

draft ``Immunotoxicity Testing Framework'' to deal specifically with 
testing for adverse effects of medical devices or constituent materials 
on the immune system. The draft guidance will provide medical device 
manufacturers with FDA's current thinking on immunotoxicity testing, 
and it will help to ensure a consistent and scientifically sound 
approach to the overall evaluation of product safety.
    The draft guidance also contains a flow chart to determine if 
immunotoxicity testing is recommended, and three tables that lead 
sequentially from potential immunological effects, to potential 
responses commonly associated with those effects, to examples of 
testing that might be considered as part of the overall safety 
evaluation of finished devices or constituent materials.
    In the past, guidances generally have been issued under 
Sec. 10.90(b) (21 CFR 10.90(b)), which provides for the use of 
guidances to state procedures or standards of general applicability 
that are not legal requirements, but that are acceptable to FDA. This 
guidance represents FDA's current thinking on the issue of 
immunotoxicity testing for medical devices and constituent materials. 
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 requirements of the applicable 
statute, regulations, or both.

II. Request for Comments

    Interested persons may, on or before June 16, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
the draft 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 draft guidance and received comments may be seen in 
the office above between 9 a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether to 
amend the current draft guidance document.

    Dated: March 6, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-6715 Filed 3-17-97; 8:45 am]
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