How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

@inproceedings{Kramer2012HowDM,
  title={How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review},
  author={Daniel B. Kramer and Shuai Xu and Aaron S Kesselheim},
  booktitle={PLoS medicine},
  year={2012}
}
BACKGROUND Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. METHODS AND FINDINGS We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that… CONTINUE READING
Recent Discussions
This paper has been referenced on Twitter 36 times over the past 90 days. VIEW TWEETS

From This Paper

Figures, tables, and topics from this paper.
23 Citations
37 References
Similar Papers

Citations

Publications citing this paper.
Showing 1-10 of 23 extracted citations

References

Publications referenced by this paper.
Showing 1-10 of 37 references

2011 February) Competitiveness and regulation: the FDA and the future of America’s biomedical industry

  • DL Gollaher, S Goodall
  • Boston Consulting Group. Available: http://www…
  • 2012
Highly Influential
5 Excerpts

Written statement: a delicate balance: FDA and the reform of the medical device approval process

  • RF Hall
  • U.S. Senate Committee on Aging. Available: http…
  • 2012
Highly Influential
8 Excerpts

Office (2009 January) FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process

  • US Government Accountabilit
  • Available: http://www.gao.gov/new.items/d09190…
  • 2012
Highly Influential
11 Excerpts

Office (2011 April 13) Medical devices: FDA’s premarket review and postmarket safety efforts

  • US Government Accountabilit
  • Available: http://www.gao.gov/ products/GAO-11…
  • 2012
Highly Influential
11 Excerpts

November) FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies

  • J Makower, A Meer, L Denend
  • Arlington (Virginia): National Venture Capital…
  • 2010
Highly Influential
3 Excerpts

The FDA PMA versus the EU CE Mark filing and approval experience: an empirical and descriptive analysis

  • R Jugo
  • J Med Device Regul
  • 2008
Highly Influential
3 Excerpts

2011 January) EU medical device approval safety assessment: a comparative analysis of medical device recalls 2005–2009

  • S Davis, E Gilbertson, S Goodall
  • Available: http://www.eucomed.org/uploads/Press…
  • 2012
2 Excerpts

Hearing: Regulatory Reform Series #5 FDA medical device regulations: impact on American patients and jobs

  • G Curfman
  • Available: http://republicans.energycommerce…
  • 2012
1 Excerpt

Similar Papers

Loading similar papers…