FDA medical device regulation and informed consent.
Smith
J J
JJ
Department of Radiology, Massachusetts General Hospital, Boston 02114, USA.
Jensen
M E
ME
Dion
J E
JE
D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D014481:United States; D014486:United States Food and Drug Administration