title: Medical device reporting: issues with Class III medical devices.
authors.affiliation: Musculoskeletal Clinical Regulatory Advisers (MCRA) in Washington, DC, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Zigler
authors.forename: John
authors.initials: J
authors.lastname: Walsh
authors.forename: Jack
authors.initials: J
authors.lastname: Zigler
mesh_terms: D008192:Deception; D018795:Device Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification / Q000266:history; D049673:History, 20th Century; D006801:Humans; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration