Modernizing device regulation

New England Journal of Medicine

Volumn 362, Issue 13, 2010, Pages 1161-1163

  Garber, Alan M ^a,b  

^a VA PALO ALTO HEALTH CARE SYSTEM   (United States)

^b STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIAC RESYNCHRONIZATION THERAPY; DEFIBRILLATOR; DEVICE; FOOD AND DRUG ADMINISTRATION; LAW SUIT; MARKETING; PACEMAKER; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SAFETY; SHORT SURVEY; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CLASSIFICATION; CLINICAL TRIAL; EQUIPMENT; GOVERNMENT REGULATION; HUMAN; JURISPRUDENCE; LEGAL ASPECT; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DEFIBRILLATORS, IMPLANTABLE; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT FAILURE; GOVERNMENT REGULATION; HUMANS; JURISPRUDENCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77950515463     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1000447     Document Type: Short Survey

References (6)

1. Food and Drug Administration. Overview of device regulation. 2010. (Accessed March 11, 2010, at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/default.htm.)
2. Mundy A, Favole JA. FDA rips approval of medical device. Wall Street Journal. September 25, 2009: A4.
3. Dhruva SS, Bero L A, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85.
4. [Erratum, JAMA 2010;303:422.]
5. Center for Devices and Radiological Health. CDRH FY 2010 strategic priorities. Washington, DC: Food and Drug Administration, 2010. (Accessed March 11, 2010, at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/ CDRHVisionandMission/UCM197648.pdf.)
6. Independent evaluation of FDA's Prescription Drug User Fee Act - evaluations and initiatives: CDER technical support and analysis: final report on the PMR/PMC backlog review. Washington, DC: Food and Drug Administration, 2009. (Accessed March 11, 2010, at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ UCM181135.pdf.)