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Comment
. 2014 Mar;92(1):151-9.
doi: 10.1111/1468-0009.12044.

Regulatory reticence and medical devices

Daniel M Fox  1 , Diana M Zuckerman
Affiliations
Comment

Regulatory reticence and medical devices

Daniel M Fox et al. Milbank Q. 2014 Mar.
No abstract available

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Comment on

References

    1. sorenson C, Drummond M. Improving medical device regulation: the US and Europe in perspective. Milbank Q. 2013;92(1):114–150. - PMC - PubMed
    1. US Department of Health and Human Services, assistant secretary for legislation. 2013. Testimony on FDA's medical device program by Michael Friedman MD http://www.hhs.gov/asl/testify/t970430a.html. Accessed December 2, 2013.
    1. Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European Union? A systematic review. PLOS Med. 2012;9(7):e1001276. doi: . - DOI - PMC - PubMed
    1. Federal Register. 2013. Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses: docket no. FDA-2013-N-0487: May http://www.gpo.gov/fdsys/pkg/FR-2013-05-21/html/2013-12122.htm. Accessed December 2, 2013.
    1. American Academy of Orthopaedic Surgeons. 2013. The 510(k) process—it's not broken, so why “fix” it? http://www.aaos.org/news/aaosnow/oct10/cover2.asp. Accessed December 2, 2013.

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