[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3826-3827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01232]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1574]


Medical Devices Containing Materials Derived From Animal Sources 
(Except for In Vitro Diagnostic Devices); Draft Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Medical Devices 
Containing Materials Derived From Animal Sources (Except for In Vitro 
Diagnostic Devices).'' FDA is issuing this draft guidance to update the 
policy regarding the use of animal-derived material in medical device 
manufacturing. These animal-derived materials may carry a risk of 
transmitting infectious disease when improperly collected, stored, or 
manufactured. The guidance describes the information you should 
document at the manufacturing facility and include in any premarket 
submissions. This draft guidance is not final nor is it in effect at 
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 23, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Medical Devices Containing Materials 
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)'' 
to the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify

[[Page 3827]]

comments with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Scott McNamee, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-5523; 
or Charles Durfor, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G424, 
Silver Spring, MD 20993-0002, 301-796-6970.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance entitled ``Medical Devices Containing Materials 
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)'' 
is intended to update the 1998 guidance of the same name regarding the 
use of animal-derived material in medical device manufacturing. The 
1998 guidance addressed ways to reduce the potential for exposure to 
bovine spongiform encephalopathy. The draft guidance continues to focus 
on the control of transmissible disease, and contains recommendations 
for documenting the source of animal tissue, conducting viral 
inactivation validation studies, as well as recommendations about the 
role of careful animal husbandry in ensuring safe tissue sources.
    The information in this guidance is applicable to all medical 
devices that contain or are exposed to animal-derived materials (e.g., 
bovine, ovine, porcine, avian materials) with the exception of in vitro 
diagnostic devices. The guidance describes the information you should 
document at the manufacturing facility and include in any premarket 
submissions. Consideration of these issues should aid in reducing the 
risk of infectious disease transmission by medical devices.
    This draft guidance, when finalized, will supersede the guidance 
entitled ``Medical Devices Containing Materials Derived from Animal 
Sources (Except for In Vitro Diagnostic Devices)'', announced in the 
Federal Register of November 6, 1998 (63 FR 60009).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on medical 
devices containing materials derived from animal sources (except for in 
vitro diagnostic devices). 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 and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Medical Devices Containing Materials Derived from Animal Sources 
(Except for In Vitro Diagnostic Devices)'' you may either send an email 
request to [email protected] to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 2206 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807 subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231; the collections 
of information in 21 CFR part 814 subpart H have been approved under 
OMB control number 0910-0332; and the collections of information in 21 
CFR part 820 have been approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01232 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P