A surgeon's perspective of medical device regulation.
Brantigan
J W
JW
Department of Surgery, Creighton University, Omaha, NE 68131, USA.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009985:Orthopedics / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D019736:Prostheses and Implants / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D013525:Surgical Instruments / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration