title: Informed consent in clinical trials of in vitro diagnostic devices: perspectives from the FDA and manufacturers.
authors.affiliation: Division of Clinical Laboratory Devices, Office of Device Evaluation, US Food and Drug Administration, Rockville, MD 20850, USA. mmm@cdrh.fda.gov
authors.forename: M M
authors.initials: MM
authors.lastname: Moxey-Mims
authors.forename: M J
authors.initials: MJ
authors.lastname: Serge
authors.forename: M N
authors.initials: MN
authors.lastname: Melvin
authors.forename: P C
authors.initials: PC
authors.lastname: Southwick
authors.forename: R T
authors.initials: RT
authors.lastname: McCormack
mesh_terms: D019411:Clinical Laboratory Techniques; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D018795:Device Approval; D006801:Humans; D007221:Industry; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration