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

Journal of Vascular Surgery

Volumn 50, Issue 6, 2009, Pages 1474-1476

  Kumar, Allison ^a   Brooks, Steven S ^a   Cavanaugh, Kenneth ^a   Zuckerman, Bram ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CATHETER; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEART ASSIST DEVICE; LIMB ISCHEMIA; MARKETING; MEDICAL INSTRUMENTATION; METHODOLOGY; PRIORITY JOURNAL; UNITED STATES;

ADVISORY COMMITTEES; CATHETERIZATION, PERIPHERAL; CONTROLLED CLINICAL TRIALS AS TOPIC; CRITICAL ILLNESS; DEVICE APPROVAL; EQUIPMENT DESIGN; EQUIPMENT SAFETY; EVIDENCE-BASED MEDICINE; EXTREMITIES; HUMANS; ISCHEMIA; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; RISK ASSESSMENT; RISK FACTORS; SOCIETIES, MEDICAL; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASCULAR SURGICAL PROCEDURES;

EID: 70649086971     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvs.2009.09.045     Document Type: Article

References (6)

1. Conte M.S., Geraghty P.J., Bradbury A.W., Hevelone N.D., Lipsitz S.R., Moneta G.L., et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg 50 (2009) 1462-1473
2. Federal Register (1976), Govt. Printing Office, Washington, DC 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.htm Accessed 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.htm Accessed on September 3, 2009.
6. 21 CFR 860.7 (c)(2) - Medical Device Classification Procedures. Washington, DC, 2008.