Biomaterial Database

FDA medical device regulation and informed consent. 1998

J J Smith, and M E Jensen, and J E Dion

Department of Radiology, Massachusetts General Hospital, Boston 02114, USA.

UI	MeSH Term	Description	Entries
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D018795	Device Approval	Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.	Device Approval Process,New Device Approval,Food and Drug Administration Device Approval,Food and Drug Administration Device Approval Process,New Device Approval Process,Approval Process, Device,Approval Processes, Device,Approval, Device,Approval, New Device,Approvals, Device,Approvals, New Device,Device Approval Processes,Device Approval, New,Device Approvals,Device Approvals, New,New Device Approvals,Process, Device Approval,Processes, Device Approval