MOST IN VITRO FERTILIZATION DEVICES NEED MOUSE EMBRYO TOXICITY DATA, PANEL AGREES; 510(K) GUIDANCE, DOWNCLASSIFICATION REG IN THE WORKS AT FDA
This article was originally published in The Gray Sheet
In vitro fertilization devices that contact the human embryo should undergo mouse embryo toxicity testing prior to FDA clearance, members of FDA's Obstetrics and Gynecology Devices Advisory Panel said at an Oct. 23 meeting in Rockville, Maryland.
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