[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]
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