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Volumn 60, Issue 2, 2005, Pages

Challenges in regulating breakthrough medical devices

Author keywords

[No Author keywords available]

Indexed keywords

SILICONE GEL;

EID: 23444443170     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (5)

References (14)
  • 2
    • 33644567789 scopus 로고    scopus 로고
    • last updated Aug. 20, last visited May 26, 2005
    • CDRH, FDA, FY 2003 CDRH ANNUAL REPORT 47 (last updated Aug. 20, 2004), available at http://www.fda.gov/cdrh/annual/fy2003/ (last visited May 26, 2005).
    • (2004) FY 2003 CDRH Annual Report 47
  • 3
    • 0032134654 scopus 로고    scopus 로고
    • Medical device problem reporting for the betterment of healthcare
    • ECRI, Medical Device Problem Reporting for the Betterment of Healthcare, 27(8) HEALTH DEVICES 277-92 (1998).
    • (1998) Health Devices , vol.27 , Issue.8 , pp. 277-292
  • 4
    • 33644581996 scopus 로고    scopus 로고
    • 21 U.S.C. § 3601 (FDCA § 522); 21 C.F.R. pt. 822-Post Market Surveillance
    • 21 U.S.C. § 3601 (FDCA § 522); 21 C.F.R. pt. 822-Post Market Surveillance.
  • 5
    • 33644566694 scopus 로고    scopus 로고
    • 21 C.F.R. § 810.13 (Apr. 1, 2004 revised version)
    • 21 C.F.R. § 810.13 (Apr. 1, 2004 revised version).
  • 6
    • 33644572912 scopus 로고    scopus 로고
    • (last updated May 31), (last visited May 26, 2005)
    • See CDRH, FDA, Medical Device Recalls (last updated May 31, 2005), at http://www.access data.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/ recalls.cfm (last visited May 26, 2005).
    • (2005) Medical Device Recalls
  • 7
    • 5344249465 scopus 로고    scopus 로고
    • Problems with drug-fluting coronary stents - The FDA perspective
    • N.I. Muni & T.P. Gross, Problems with Drug-Fluting Coronary Stents-The FDA Perspective, 351 NEW ENG. J. MED. 1593-95 (2004).
    • (2004) New Eng. J. Med. , vol.351 , pp. 1593-1595
    • Muni, N.I.1    Gross, T.P.2
  • 8
    • 0037448393 scopus 로고    scopus 로고
    • Ensuring safe and effective medical devices
    • D.W. Feigal, S.N. Gardner & M. McClellan, Ensuring Safe and Effective Medical Devices, 348(3) NEW ENG. J. MED. 191-92 (2003).
    • (2003) New Eng. J. Med. , vol.348 , Issue.3 , pp. 191-192
    • Feigal, D.W.1    Gardner, S.N.2    McClellan, M.3
  • 9
    • 33644561303 scopus 로고    scopus 로고
    • last visited May 17, 2005
    • See FDA, Patient Safety News, at http://www.fda.gov/psn (last visited May 17, 2005).
    • Patient Safety News
  • 14
    • 33644572688 scopus 로고    scopus 로고
    • Adverse events should be reported to http:www.fda.gov/cdrh/mdr.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.