Document Detail


FDA regulation of technology and surgical devices in the operating room.
MedLine Citation:
PMID:  14551653     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Neil Ogden
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Seminars in laparoscopic surgery     Volume:  10     ISSN:  1071-5517     ISO Abbreviation:  Semin Laparosc Surg     Publication Date:  2003 Sep 
Date Detail:
Created Date:  2003-10-10     Completed Date:  2004-04-02     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  9432584     Medline TA:  Semin Laparosc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  115-9     Citation Subset:  IM    
Affiliation:
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
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MeSH Terms
Descriptor/Qualifier:
Biomedical Technology / legislation & jurisprudence*,  trends*
Device Approval / legislation & jurisprudence*
Humans
Operating Rooms / trends*
Surgical Equipment / trends*
Surgical Instruments / trends*
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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