메뉴 건너뛰기




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

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

Author keywords

[No Author keywords available]

Indexed keywords

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

EID: 78149376593     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2010.323     Document Type: Note
Times cited : (15)

References (11)
  • 3
    • 73949084847 scopus 로고    scopus 로고
    • Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
    • 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.
    • (2009) JAMA , vol.302 , Issue.24 , pp. 2679-2685
    • Dhruva, S.S.1    Bero, L.A.2    Redberg, R.F.3
  • 4
    • 77950515463 scopus 로고    scopus 로고
    • Modernizing device regulation
    • Garber AM. Modernizing device regulation.NEngl J Med. 2010;362(13):1161-1163.
    • (2010) NEngl J Med , vol.362 , Issue.13 , pp. 1161-1163
    • Garber, A.M.1
  • 5
    • 74549144459 scopus 로고    scopus 로고
    • Accessed July 26, 2010
    • Critical Path Initiative. http://www.fda.gov/ScienceResearch/ SpecialTopics /CriticalPathInitiative/default.htm. Accessed July 26, 2010.
    • Critical Path Initiative
  • 7
    • 84873546382 scopus 로고    scopus 로고
    • Recovery Filter System. Accessed July 29, 2010
    • Recovery Filter System. 510(k) Summary of Safety and Effectivenes Information. http://www.accessdata.fda.gov/cdrh-docs/pdf2/K022236.pdf. Accessed July 29, 2010.
    • 510(k) Summary of Safety and Effectivenes Information
  • 8
    • 78149383832 scopus 로고    scopus 로고
    • Recovery Filter System. Accessed July 29, 2010
    • Recovery Filter System. Abbreviated 510(k). http://www.accessdata.fda.gov /cdrh-docs/pdf3/K031328.pdf. Accessed July 29, 2010.
    • Abbreviated 510(k)
  • 9
    • 78149398684 scopus 로고    scopus 로고
    • G2 Filter With Femoral Delivery. Accessed July 29, 2010
    • 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.
    • Traditional 510(k). Summary of Safety and Effectiveness
  • 10
    • 77953955207 scopus 로고    scopus 로고
    • Transparency at the Food and Drug Administration
    • published online May 19, 2010
    • Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration [published online May 19, 2010]. N Engl J Med. 2010;362(25): 2341-2343.
    • (2010) N Engl J Med , vol.362 , Issue.25 , pp. 2341-2343
    • Asamoah, A.K.1    Sharfstein, J.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.