Document Detail


The role of the U.S. Food and Drug Administration in device evaluation and monitoring.
MedLine Citation:
PMID:  20421100     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.
Authors:
; David L Diehl; William M Tierney; Douglas G Adler; Jason D Conway; Francis A Farraye; Sergey V Kantsevoy; Vivek Kaul; Sripathi R Kethu; Richard S Kwon; Petar Mamula; Marcos C Pedrosa; Sarah A Rodriguez
Publication Detail:
Type:  Journal Article; Review     Date:  2010-04-24
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  72     ISSN:  1097-6779     ISO Abbreviation:  Gastrointest. Endosc.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-12     Completed Date:  2010-11-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5-10     Citation Subset:  IM    
Copyright Information:
Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Animals
Compassionate Use Trials / legislation & jurisprudence
Device Approval / legislation & jurisprudence*
Endoscopes, Gastrointestinal / classification,  standards*
Equipment Failure*
Equipment Safety / standards
Humans
Medical Device Recalls / legislation & jurisprudence
Off-Label Use / legislation & jurisprudence
Product Surveillance, Postmarketing
Surgical Procedures, Minimally Invasive / classification,  instrumentation*,  legislation & jurisprudence*
United States
United States Food and Drug Administration / legislation & jurisprudence*

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


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