80 FR 61820 - General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 198 (October 14, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``General Considerations for Animal Studies for Medical Devices.'' FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61820-61822]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3419]


General Considerations for Animal Studies for Medical 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Draft Guidance for Industry and Food and Drug Administration Staff; 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 or Agency) is announcing 
the availability of the draft guidance entitled ``General 
Considerations for Animal Studies for Medical Devices.'' FDA has 
developed this guidance document to assist industry in designing 
evaluation strategies for, and reporting the results of, animal studies 
for medical devices. The intent of this draft guidance is to provide a 
reference of best practices for the approach to, and conduct of, animal 
studies, and the presentation of animal study data intended to 
demonstrate that the device under study is sufficiently safe for early 
human experience (e.g., to support an investigational device exemption 
(IDE) application) or to demonstrate device safety in support of a 
marketing application, while incorporating modern animal care and use 
strategies. 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 January 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential,

[[Page 61821]]

if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3419 for ``General Considerations for Animal Studies for 
Medical Devices.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 draft guidance document entitled 
``General Considerations for Animal Studies for Medical 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: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in 
designing evaluation strategies for, and reporting the results of, 
animal studies for medical devices. The animal studies utilized for the 
assessment of these devices typically provide initial evidence of 
device safety, their potential performance when used in a living 
system, and the biologic response that a living system may mount 
towards the device. The intent of this guidance is to provide a 
reference of best practices for the approach to, and conduct of, animal 
studies, and the presentation of animal study data intended to 
demonstrate that the device under study is sufficiently safe for early 
human experience (e.g., to support an investigational device exemption 
application) or to demonstrate device safety in support of a marketing 
application, while incorporating modern animal care and use strategies. 
We encourage sponsors to consult with us if it they wish to use a non-
animal testing method they believe is suitable, adequate, validated, 
and feasible. We will consider if such an alternative method could be 
assessed for equivalency to an animal test method.
    This draft guidance, when finalized, will supersede the July 2010 
guidance entitled ``Guidance for Industry and FDA Staff: General 
Considerations for Animal Studies for Cardiovascular Devices.''

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 current thinking of FDA on General 
Considerations for Animal Studies for Medical 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``General Considerations for 
Animal Studies for Medical Devices,'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1802 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 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR part 58 have been approved 
under OMB control number 0910-0119; 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, subparts A through E, have been 
approved under OMB control numbers 0910-0231; and the collections of 
information in 21 CFR part 814, subpart H have been approved under OMB 
control number 0910-0332.
    This draft guidance also refers to proposed collections of 
information described in FDA's August 14, 2014, draft guidance 
entitled, ``De Novo Classification Process (Evaluation of Automatic 
Class III Designations)'' (de novo draft guidance) (79 FR 47651). The 
proposed collections of information described in the de novo draft 
guidance are subject to review by OMB under the PRA. As required by the 
PRA, FDA has published an analysis of the proposed information 
collection described in the de novo draft guidance (79 FR 47651 at 
47653) and has submitted them for OMB approval.


[[Page 61822]]


    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26055 Filed 10-13-15; 8:45 am]
BILLING CODE 4164-01-P