FDA regulation of technology and surgical devices in the operating room.
Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.
Ogden
Neil
N
General Surgery Devices Branch (GSDB),Division of General, Restorative and Neurological Devices,Office of Device Evaluation (ODE),Center for Devices and Radiological Health,Food and Drug Administration, Rockville, Maryland, USA. nro@cdrh.fda.gov
D020811:Biomedical Technology / Q000331:legislation & jurisprudence* / Q000639:trends*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009873:Operating Rooms / Q000639:trends*; D013523:Surgical Equipment / Q000639:trends*; D013525:Surgical Instruments / Q000639:trends*; D014481:United States