Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review-Reference-Cited by-同舟云学术

Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

Published:2010-07-13 Issue:7 Volume:7 Page:e1000280
ISSN:1549-1676
Container-title:PLoS Medicine
language:en
Short-container-title:PLoS Med

Author:

Hines Jonas Zajac,Lurie Peter,Yu Eunice,Wolfe Sidney

Publisher

Public Library of Science (PLoS)

Subject

General Medicine

Reference62 articles.

1. Definition of a medical device.,2006

2. The limited state of technology assessment for medical devices: facing the issues.;SD Ramsey;Am J Manag Care,1998

3. Elevated risk of pelvic inflammatory disease among women using the Dalkon Shield.;Morb Mortal Wkly Rep,1983

4. The Bjork-Shiley heart valve: earn as you learn; Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation: a staff report.,1990

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