Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval

JAMA

Volumn 308, Issue 17, 2012, Pages 1740-1742

  Chen, Connie E ^a   Dhruva, Sanket S ^b   Redberg, Rita F ^c  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84868313703     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.14491     Document Type: Letter

References (4)

1. Food and Drug Administration. Determination of safety and effectiveness (§860.7): valid scientific evidence. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ PremarketApprovalPMA/ucm050419.htm. Accessed July 10, 2012.
2. Goldberg NH, Schneeweiss S, et al. Availability of comparative effectiveness data at the time of drug approval in the United States. JAMA. 2011;305(17):1786-1789.
3. Dhruva SS, Bero LA, Redberg RF. The strength of study evidence examined by the FDA in pre-market approval of cardiovascular devices. JAMA. 2009;302(24):2679-2685.
4. Food and Drug Administration. FDA summary of safety and effectiveness data (SSED) clinical section checklist. http://www.fda.gov/AboutFDA/ CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ ucm220413.htm. Accessed September 17, 2012.