IDE, PMA program integrity audit initiated by HHS IG.
This article was originally published in The Gray Sheet
IDE, PMA PROGRAM INTEGRITY AUDIT RECOMMENCED BY HHS IG, FDA staffers say. The HHS Inspector General's inquiry will focus on the adequacy of FDA mechanisms that are in place to protect the investigational device exemption and premarket approval application programs from waste, fraud and abuse. IG staffers held an "entrance conference" kicking off the audit the week of Jan. 9, according to FDAers.
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