Medical devices and the FDA approval process: Balancing safety and innovation

Archives of Internal Medicine

Volumn 170, Issue 20, 2010, Pages 1831-1833

  Redberg, Rita F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FOOD AND DRUG ADMINISTRATION; MEDICAL INSTRUMENTATION; NOTE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT;

CARDIAC TAMPONADE; DEVICE APPROVAL; EMBOLISM; HEART INJURIES; HUMANS; PREVALENCE; PROSTHESIS DESIGN; PROSTHESIS FAILURE; PULMONARY EMBOLISM; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VENA CAVA FILTERS;

EID: 78149376593     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2010.323     Document Type: Note

References (11)

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3. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009; 302(24):2679-2685.
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9. G2 Filter With Femoral Delivery. Traditional 510(k). Summary of Safety and Effectiveness. http://www.accessdata.fda.gov/cdrh-docs/pdf5/K050558 .pdf. Accessed July 29, 2010.
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11. Boston Sci confirms problems in 3 ICD models. http://www.reuters.com /assets/print?aid=USN2222410920100722. Accessed July 26, 2010.