title: Medical-device safety and the FDA.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Schultz
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017147:Defibrillators, Implantable; D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011475:Prosthesis Failure; D014481:United States; D014486:United States Food and Drug Administration