[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Medical Devices; Immunotoxicity Testing Framework; Draft
Guidance; Availability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availability of a draft guidance entitled ``Immunotoxicity Testing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 The draft guidance will also aid in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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Immunotoxicity Testing Framework'' to the Division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 The draft guidance is also available via the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Submit written comments on the draft guidance to the Dockets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 A copy of the draft guidance and received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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