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Volumn , Issue , 2007, Pages 3556-3558

Issues associated with off label use of medical devices

Author keywords

Clinical use; EC; FDA; Instruction for use; Label; Medical devices; Regulation; Risk

Indexed keywords

DEVICE LABELING; LABEL USE; MEDICAL DEVICES;

EID: 57649216672     PISSN: 05891019     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/IEMBS.2007.4353099     Document Type: Conference Paper
Times cited : (10)

References (4)
  • 1
    • 38049011578 scopus 로고    scopus 로고
    • The 1997 FDA Modernization Act (FDAMA) described certain conditions under which a manufacturer could disseminate information on new uses without incurring regulatory objections.
    • The 1997 FDA Modernization Act (FDAMA) described certain conditions under which a manufacturer could disseminate information on new uses without incurring regulatory objections.
  • 2
    • 38049080097 scopus 로고    scopus 로고
    • Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices, 21 CFR Parts 16 and 99, Federal Register, 63, No. 2241, November 20, 1998.
    • "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices", 21 CFR Parts 16 and 99, Federal Register, Vol. 63, No. 2241, November 20, 1998.
  • 3
    • 38049002649 scopus 로고    scopus 로고
    • Decision in Washington Legal Foundation vs. Henny, Federal Register, 65, No. 52, 14286-14288, March 16, 2000. See also www.fda.gov/OHRMS/DOCKETS/ 98fr/031688 B.txt.
    • Decision in Washington Legal Foundation vs. Henny, Federal Register, Vol. 65, No. 52, 14286-14288, March 16, 2000. See also www.fda.gov/OHRMS/DOCKETS/ 98fr/031688 B.txt.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.