title: FDA unveils 25 initial 510(k) changes, refers controversial recommendations to the Institute of Medicine (IOM).
authors: McGuire Woods LLP, Washington, DC, USA. mgilmore@mcguirewoods.com
authors: Melissa
authors: M
authors: Gilmore
authors: Joseph J
authors: JJ
authors: Hylak-Reinholtz
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D014481:United States; D014486:United States Food and Drug Administration