[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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