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Gastrointestinal Endoscopy
Volume 72, Issue 1
, Pages 5-10
, July 2010
The role of the U.S. Food and Drug Administration in device evaluation and monitoring
References
- . Primer on medical device regulation (Part I. History and background). Radiology. 1997;205:1–9
- In: Field MJ, Tilson H editor. Institute of Medicine (Safe medical devices for children). Washington, DC: The National Academies Press; 2005;
- FDA overview of device regulation. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htmAccessed on March 9, 2010
- Food, Drug and Cosmetic Act. 21 USC §201(h). http://www.fda.gov/opacom/laws/fdcact/fdcact1.htmAccessed December 15, 2008
- . Medical Device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140:296–302
- . In F.D.A. files, claims of rush to approve devices. In: New York Times; January 13, 2009;p. A14
- . The 501(k) process: the key to effective device regulation. http://www.advamed.org/NR/rdonlyres/933087B7-1856-4D39-94D7-B96DC89D1762/0/510KWhitePaper.pdfAccessed January 20, 2009
- . Primer on Medical Device Regulation (Part II. Regulation of medical devices by the U.S. Food and Drug Administration). Radiology. 1997;205:10–18
- Manufacturer and User Facility Device Experience (MAUDE) Database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMAccessed March 7, 2009
- Medical product safety network. http://www.medsun.net/about2.aspAccessed December 15, 2008
- FDA consumer alerts and recalls. http://www.fda.gov/consumer/updates/recalls123107.htmlAccessed March 6, 2009
- FDA enforcement statistics. http://www.fda.gov/cdrh/oivd/meetings/041806/bernier.pptAccessed March 6, 2009
- . Ensuring safe and effective medical devices. N Engl J Med. 2003;348:191–192
- FDA postings of recalls, market withdrawals, and safety alerts. http://www.fda.gov/opacom/7alerts.htmlAccessed March 6, 2009
- FDA list of device recalls. http://www.fda.gov/cdrh/recalls/recall-050404.htmlAccessed March 9, 2009
This document is a product of the ASGE Technology Assessment Committee. This document was reviewed and approved by the governing board of the ASGE.
PII: S0016-5107(10)00038-6
doi: 10.1016/j.gie.2010.01.024
© 2010 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
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Gastrointestinal Endoscopy
Volume 72, Issue 1
, Pages 5-10
, July 2010
