title: New medical devices: the author's reply to Brock.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Zinn
authors.forename: John C
authors.initials: JC
authors.lastname: Allen
authors.forename: Carl S
authors.initials: CS
authors.lastname: Hacker
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000145:classification*; D014486:United States Food and Drug Administration