[Federal Register Volume 63, Number 215 (Friday, November 6, 1998)]
[Notices]
[Pages 60009-60010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29750]
[[Page 60009]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0924]
Medical Devices Containing Materials Derived From Animal Sources
(Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers
and Industry; 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 ``Medical Devices Containing
Materials Derived From Animal Sources (Except for In Vitro Diagnostic
Devices), Guidance for FDA Reviewers and Industry.'' This guidance is
intended to provide recommendations for information that is to be
included in premarket submissions--investigational device exemption
(IDE), premarket approval application (PMA), and 510(k) submisions for
medical devices that either contain or are exposed to animal-derived
materials during manufacturing.
DATES: Written comments concerning this guidance must be received by
February 4, 1999. Comments submitted after February 4, 1999, must be
submitted to one of the contact persons.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Medical Devices Containing Materials Derived From
Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for
FDA Reviewers and Industry'' 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. Written
comments concerning this guidance must be submitted to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the docket number found in brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT: Karen F. Warburton, Office of Device
Evaluation (HFZ-460), or Kiki B. Hellman, Office of Science and
Technology (HFZ-113), Center for Devices and Radiological Health, Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-443-7158.
SUPPLEMENTARY INFORMATION:
I. Background
FDA believes that an animal disease such as bovine spongiform
encephalopathy (BSE) is a concern in the manufacture of FDA-regulated
products intended for administration to humans. In 1993 and, more
recently, on May 6, 1996, FDA issued letters to manufacturers to
request that bovine-derived materials from cattle which have resided in
or originated from countries where BSE has been diagnosed (as
designated by the U.S. Department of Agriculture) not be used in the
manufacture of FDA-regulated products. To identify medical devices
which either contain or are exposed to animal-derived materials during
manufacturing, CDRH developed the biomaterials database that contains
an inventory of these devices, including type of material, animal
species and county of origin, and target organ or tissue for each
device. Originally proposed in response to the BSE issue, the database
was expanded to include all animal-derived products (including human)
in order to respond to other animal-based sourcing concerns that may
arise in the future.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
medical devices containing materials derived from animal sources. 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 document is issued as a Level 1 guidance
consistent with GGP's. The agency is accepting public comments, but it
is implementing this guidance immediately because of public health
concerns related to the use of bovine-derived materials in medical
devices and the agency's previous communication to manufacturers on
this subject.
III. Electronic Access
In order to receive ``Medical Devices Containing Materials Derived
From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance
for FDA Reviewers and Industry'' 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
(2206) 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 Web.
Updated on a regular basis, the CDRH home page includes ``Medical
Devices Containing Materials Derived From Animal Sources (Except In
Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry,''
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. ``Medical Devices Containing
Materials Derived From Animal Sources (Except for In Vitro Diagnostic
Devices), Guidance for FDA Reviewers and Industry'' will be available
at http://www.fda.gov/cdrh/ode/guid.html.
IV. Comments
Interested persons may, on or before February 4, 1999, submit to
Dockets Management Branch (address above) written comments regarding
this immediately in effect guidance. At any time after 90 days from the
date of publication in the Federal Register, submit to the contact
person (address above) written comments regarding this guidance. Such
comments will be considered when determining whether to amend the
current 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 guidance document and received comments may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
[[Page 60010]]
Dated: October 28, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-29750 Filed 11-5-98; 8:45 am]
BILLING CODE 4160-01-F