title: U.S. FDA rules for device investigations.
authors.forename: Robert
authors.initials: R
authors.lastname: Munzner
mesh_terms: D001698:Biomedical Engineering / Q000295:instrumentation* / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D032962:Consent Forms / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D033161:Government Regulation; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration