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Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices Instructions: All submissions received must include the Docket No. FDA
2019D2105 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
An electronic copy of the guidance document is available for download from the internet. See the
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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 209930002. Send one selfaddressed adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: PeiHsuan Chris Hung, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2647, Silver Spring, MD 209930002, 2404025928.
SUPPLEMENTARY INFORMATION:

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 FDAs 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.

I. Background
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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https www.regulations.gov and at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 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.

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 liquidbased test articles should be prepared per the instructions for use; clarify FDAs recommended exposure time for test articles depending on their clinical use duration; include additional
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II. Electronic Access
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:

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