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The Is A Good START

Posted by H. Sandra Chevalier-Batik
The New England Journal of MedicineEditorial
Published at www.nejm.org March 18, 2009 (10.1056/NEJMe0902377)
The Medical Device Safety Act of 2009

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.


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- PubMed Citation

  • Challenges for the FDA: the future of drug safety — workshop summary. Washington, DC: National Academies Press, 2007.
  • Riegel v. Medtronic, 552 U.S. 2 (2008).
  • Kyle RH. In re Medtronic, Inc. Sprint Fidelis leads products liability litigation. Multidistrict litigation no. 08-1905 (RHK/JSM). Memorandum opinion and order. U.S. District Court of Minnesota. January 5, 2009. (Accessed March 17, 2009, at http://www.mnd.uscourts.gov/MDL-Fidelis/Orders/2009/090105-08md1905ord.pdf.)
  • Meier B. Medtronic links device for heart to 13 deaths. New York Times. March 13, 2009.
  • Medtronic letter to physicians: Sprint Fidelis model 6949 lead performance. (Accessed March 17, 2009, at http://www.medtronic.com/product-advisories/physician/sprint-fidelis/PHYSLETTER-2009-03-13.htm.)
  • Medical Device Amendments of 1976, codified at 21 U.S.C. § 360(k)(a).
  • Wyeth v. Levine, 555 U.S. 2 (2009).
  • Committee on Energy and Commerce. Health leaders introduce legislation reversing Supreme Court’s medical device decision. (Accessed March 17, 2009, at http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1518.)
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