The medical device safety act of 2009

New England Journal of Medicine

Volumn 360, Issue 15, 2009, Pages 1550-1551

  Curfman, Gregory D ^a   Morrissey, Stephen ^a   Drazen, Jeffrey M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COURT; DEVICE; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE POLICY; HUMAN; LAW ENFORCEMENT; PATIENT SAFETY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; DRUG INDUSTRY; DRUG LEGISLATION; EQUIPMENT; JURISPRUDENCE; LEGAL ASPECT; LEGAL LIABILITY; MEDICOLEGAL ASPECT; SAFETY; UNITED STATES;

DEVICE APPROVAL; DRUG INDUSTRY; EQUIPMENT SAFETY; LEGISLATION, DRUG; LEGISLATION, MEDICAL; LIABILITY, LEGAL; STATE GOVERNMENT; SUPREME COURT DECISIONS; UNITED STATES;

EID: 64349092072     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMe0902377     Document Type: Editorial

References (8)

1. Challenges for the FDA: the future of drug safety - workshop summary. Washington, DC: National Academies Press, 2007.
2. Riegel v. Medtronic, 552 U.S. 2 (2008).
3. 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 20, 2009, at http://www.mnd.uscourts.gov/MDL-Fidelis/Orders/2009/090105- 08md1905ord.pdf.)
4. Meier B. Medtronic links device for heart to 13 deaths. New York Times. March 13, 2009:B1.
5. Medtronic letter to physicians: Sprint Fidelis model 6949 lead performance. (Accessed March 20, 2009, at http://www.medtronic.com/product- advisories/physician/sprint-fidelis/PHYSLETTER-2009-03-13.htm.)
6. Medical Device Amendments of 1976, codified at 21 U.S.C. § 360(k)(a).
7. Wyeth v. Levine, 555 U.S. 2 (2009).
8. Committee on Energy and Commerce. Health leaders introduce legislation reversing Supreme Court's medical device decision. (Accessed March 20, 2009, at http://energycommerce.house.gov/index.php?option=com-content&task= view&id=1518.)