Biomaterial Database

U.S. FDA rules for device investigations. 2003

Robert Munzner

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
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D001698	Biomedical Engineering	Application of principles and practices of engineering science to biomedical research and health care.	Clinical Engineering,Engineering, Clinical,Engineering, Biomedical
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
D032962	Consent Forms	Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.	Consent Documents,Informed Consent Forms,Informed Consent Documents,Consent Document,Consent Document, Informed,Consent Documents, Informed,Consent Form,Document, Informed Consent,Documents, Informed Consent,Informed Consent Document,Informed Consent Form
D033161	Government Regulation	Exercise of governmental authority to control conduct.	Government Regulation and Oversight,Government Regulations,Regulation, Government,Regulations, Government

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