Informed consent in clinical trials of in vitro diagnostic devices: perspectives from the FDA and manufacturers.
Moxey-Mims
M M
MM
Division of Clinical Laboratory Devices, Office of Device Evaluation, US Food and Drug Administration, Rockville, MD 20850, USA. mmm@cdrh.fda.gov
Serge
M J
MJ
Melvin
M N
MN
Southwick
P C
PC
McCormack
R T
RT
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