Document ID: FDA-2019-D-2105-0009
Agency: fda
Document Type: Notice
Title: Mouse Embryo Assay for Assisted Reproduction Technology Devices;
Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2021-01-05T05:00Z

[Federal Register Volume 86, Number 2 (Tuesday, January 5, 2021)]
[Notices]
[Pages 312-314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2105]

Mouse Embryo Assay for Assisted Reproduction Technology 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 ``Mouse Embryo Assay for 
Assisted Reproduction Technology Devices.'' This guidance document 
provides recommendations on conducting the mouse embryo assay to 
support premarket submissions and lot release of assisted reproduction 
technology devices.

DATES: The announcement of the guidance is published in the Federal 
Register on January 5, 2021.

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.''

[[Page 313]]

    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-2105 for ``Mouse Embryo Assay for Assisted Reproduction 
Technology 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 
``Mouse Embryo Assay for Assisted Reproduction Technology Devices'' to 
the Office of Policy, 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: Pei-Hsuan (Chris) Hung, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2647, Silver Spring, MD 20993-0002, 
240-402-5928.

SUPPLEMENTARY INFORMATION:

I. Background

    The majority of assisted reproduction technology (ART) devices 
directly or indirectly contact gametes and/or embryos during use. The 
mouse embryo assay (MEA) is used to assess the potential for 
embryotoxicity of devices that contact gametes and/or embryos. Several 
classification regulations under part 884 (21 CFR part 884) include 
special controls that require MEA testing or information. MEA may also 
be used by sponsors to support premarket submissions for other devices 
that are intended to contact gametes and/or embryos during their use. 
However, there are no voluntary consensus standards that describe how 
to conduct the MEA. This guidance provides recommendations for 
conducting the MEA to support premarket submissions and lot release for 
ART devices that are intended to contact gametes and/or embryos and to 
comply with the special controls for those devices classified under 
part 884 that require MEA testing or information.
    A notice of availability of the draft guidance appeared in the 
Federal Register of June 13, 2019 (84 FR 27637). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including minor technical edits and clarifications. 
Specifically, the final guidance includes revisions to recommend that 
liquid-based test articles should be prepared per the instructions for 
use; clarify FDA's recommended exposure time for test articles 
depending on their clinical use duration; include additional 
specificity on the number of embryos that should be used; discuss how 
accelerated aging can also be used to develop test articles at the end 
of the proposed shelf-life; and when procedural modifications or 
options should be justified in the test report. In addition, FDA made 
editorial changes to the guidance for clarity.
    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 ``Mouse Embryo Assay for Assisted 
Reproduction Technology 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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Mouse Embryo Assay for Assisted 
Reproduction Technology Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16015 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

[[Page 314]]

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                                                            OMB control
            21 CFR part                     Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     Notification.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
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    Dated: December 28, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29081 Filed 1-4-21; 8:45 am]
BILLING CODE 4164-01-P