The FDA's role in medical device clinical studies of human subjects.
This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.
Saviola
James
J
Vitreoretinal and Extraocular Devices Branch, Division of Ophthalmic and ENT Devices, Office of Device Evaluation, CDRH, FDA, USA.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D019736:Prostheses and Implants / Q000592:standards*; D012164:Retinal Diseases / Q000534:rehabilitation*; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*