[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]



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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.


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    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