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 

  1. Monsein LH. Primer on medical device regulation (Part I. History and background). Radiology. 1997;205:1–9
  2. In:  Field MJ,  Tilson H editor. Institute of Medicine (Safe medical devices for children). Washington, DC: The National Academies Press; 2005;
  3. FDA overview of device regulation. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htmAccessed on March 9, 2010
  4. Food, Drug and Cosmetic Act. 21 USC §201(h). http://www.fda.gov/opacom/laws/fdcact/fdcact1.htmAccessed December 15, 2008
  5. Maisel WH. Medical Device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140:296–302
  6. Harris G. In F.D.A. files, claims of rush to approve devices. In: New York Times; January 13, 2009;p. A14
  7. AdvaMed (Advanced Medical Technology Association). 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
  8. Monsein LH. Primer on Medical Device Regulation (Part II. Regulation of medical devices by the U.S. Food and Drug Administration). Radiology. 1997;205:10–18
  9. Manufacturer and User Facility Device Experience (MAUDE) Database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMAccessed March 7, 2009
  10. Medical product safety network. http://www.medsun.net/about2.aspAccessed December 15, 2008
  11. FDA consumer alerts and recalls. http://www.fda.gov/consumer/updates/recalls123107.htmlAccessed March 6, 2009
  12. FDA enforcement statistics. http://www.fda.gov/cdrh/oivd/meetings/041806/bernier.pptAccessed March 6, 2009
  13. Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med. 2003;348:191–192
  14. FDA postings of recalls, market withdrawals, and safety alerts. http://www.fda.gov/opacom/7alerts.htmlAccessed March 6, 2009
  15. 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

Gastrointestinal Endoscopy
Volume 72, Issue 1 , Pages 5-10 , July 2010