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GUIDANCE DOCUMENT

Mouse Embryo Assay for Assisted Reproduction Technology Devices June 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Mouse Embryo Assay for Assisted Reproduction Technology Devices

Submit Comments by 08/12/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-2105


Docket Number:
FDA-2019-D-2105
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this draft guidance to outline draft recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices. The majority of ART devices directly or indirectly contact gametes (i.e., sperm and oocytes) and/or embryos during their intended use. MEA is used to assess the potential for embryotoxicity of devices that contact gametes and/or embryos. Several classification regulations under 21 CFR part 884 include special controls that require MEA testing or information. MEA may also be used 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 This draft guidance provides recommendations for conducting the MEA to support premarket submissions for devices that are intended to contact gametes and/or embryos and to comply with the special controls for those devices classified under 21 CFR 884 that require MEA testing or information.