Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Language(s):
English
Format:
Text
Subject(s):
Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
FDA is issuing this guidance to outline 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., spermand oocytes) and/or embryos during their intended use. MEA is used to assess the potential forembryotoxicity of devices that contact gametes and/or embryos. Several classificationregulations under 21 CFR part 884 include special controls that require MEA testing orinformation. MEA may also be used to support premarket submissions for other devices that areintended to contact gametes and/or embryos during their use. However, there are no voluntaryconsensus standards that describe how to conduct the MEA. This guidance providesrecommendations for conducting the MEA to support premarket submissions for devices that areintended to contact gametes and/or embryos and to comply with the special controls for thosedevices classified under 21 CFR 884 that require MEA testing or information.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (6 pages)).
NLM Unique ID:
9918250312006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918250312006676