120-DAY PMA REVIEW PROCESS FOR WELL-UNDERSTOOD PRODUCTS TO BE TESTED FOR IN VITRO DIAGNOSTICS; PMA SUPPLEMENT DRAFT GUIDANCE DOCUMENT NEARING COMPLETION
This article was originally published in The Gray Sheet
Executive SummaryAn FDA proposal for a 120-day fast-track review of premarket approval applications for well-understood products is expected to be sent to manufacturers for comment by the end of November.
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