[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9530-9531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04883]



[[Page 9530]]

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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); Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Medical Devices 
Containing Materials Derived from Animal Sources (Except for In Vitro 
Diagnostic Devices).'' FDA is issuing this 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 manufacturers 
should document at the manufacturing facility and include in any 
premarket submissions.

DATES: The announcement of the guidance is published in the Federal 
Register on March 15, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1574 for ``Medical Devices Containing Materials Derived from 
Animal Sources (Except for In Vitro Diagnostic Devices).'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Medical Devices Containing Materials Derived from Animal Sources 
(Except for In Vitro Diagnostic Devices)'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Anjana Jain, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G450, Silver Spring, MD 20993-0002, 301-796-6363; 
or 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.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance entitled ``Medical Devices Containing Materials 
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)'' 
updates the November 6, 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 revised guidance continues to 
focus on the control of

[[Page 9531]]

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 revised guidance also 
includes recommendations related to viral pathogens and all 
transmissible spongiform encephalopathies.
    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 and materials generally recognized to be safe based 
on their method of manufacture. This guidance provides: (1) Information 
that FDA believes is important to document the safe and consistent 
manufacture of medical devices containing animal tissue; (2) 
information that should be included in a premarket submission for 
products within the scope of this guidance; (3) recommendations 
regarding how specific aspects of the Quality System (QS) Regulation 
should be applied to control and document the safe and consistent 
manufacture of medical devices containing animal tissue; and (4) 
additional information on specific approaches for determining the 
ability of manufacturing methods to eliminate viral contamination in 
the final product. Consideration of these items should aid in reducing 
the risk of infectious disease transmission by medical devices. FDA 
considered comments received on the draft guidance that appeared in the 
Federal Register of January 23, 2014 (79 FR 3826). FDA revised the 
guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on medical devices containing materials derived 
from animal sources (except for in vitro diagnostic devices). It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Medical Devices 
Containing Materials Derived from Animal Sources (Except for In Vitro 
Diagnostic Devices)'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 2206 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

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 21 CFR part; guidance; or FDA
             form                       Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
``De Novo Classification        De Novo                        0910-0844
 Process (Evaluation of          classification
 Automatic Class III             process.
 Designation)''.
``Requests for Feedback on      Q-submissions........          0910-0756
 Medical Device Submissions:
 The Pre-Submission Program
 and Meetings with Food and
 Drug Administration Staff''.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
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    Dated: March 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04883 Filed 3-14-19; 8:45 am]
BILLING CODE 4164-01-P