[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]
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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(Except for In Vitro Diagnostic Devices); Draft Guidance for Industry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.
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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availability of the draft guidance entitled ``Medical Devices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 FDA is issuing this draft guidance to update the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 This draft guidance is not final nor is it in effect at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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 23, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Medical Devices Containing Materials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Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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