Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1474-1476 , December 2009

FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia

  • Allison Kumar, BS

      Affiliations

    • Corresponding Author InformationReprint requests: Allison Kumar, BS, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Cardiovascular Devices, 10903 New Hampshire Ave., WO66-1270, Silver Spring, MD 20993
    • ,
  • Steven S. Brooks, MD
    • ,
  • Kenneth Cavanaugh, PhD
    • ,
  • Bram Zuckerman, MD

Received 18 September 2009 ,Accepted 22 September 2009.

References 

  1. Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009;50:1462–1473
  2. Federal Register. Washington, DC: Govt. Printing Office; 1976;43FR 32988.
  3. Food Drug and Cosmetic Act Amendment. Federal Register 1998;63(225):64617 (21U.S.C.396. Section 906).
  4. Statistical guidance for clinical trials of non-diagnostic medical devices. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106757.htmAccessed on September 3, 2009.
  5. Least burdensome provisions of the FDA Modernization Act of 1997: concept and principles; final guidance for FDA and industry. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htmAccessed on September 3, 2009.
  6. 21 CFR 860.7 (c)(2) - Medical Device Classification Procedures. Washington, DC, 2008.

 Competition of interest: none.

 The views and opinions are those of the authors and do not necessarily reflect those of the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, or the Public Health Service.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)01935-1

doi: 10.1016/j.jvs.2009.09.045

Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1474-1476 , December 2009

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