The US food and drug administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: Information for the investigator

Journal of Vascular Surgery

Volumn 29, Issue 3, 1999, Pages 566-574

  Pritchard W F , Jr ^a   Abel, D B ^a   Karanian, J W ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CARDIOVASCULAR EQUIPMENT; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REVIEW; SAFETY;

EID: 0033039001     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0741-5214(99)70288-0     Document Type: Review

References (16)

1. Federal Food, Drug, and Cosmetic Act, Sect 520 (g)(1).
2. 21 CFR Sect 812.1(a).
3. 21 CFR Sect 812.2 (c).
4. 21 CFR Sect 812.3 (m).
5. WF Pritchard RF Carey U.S. Food and Drug Administration and regulation of medical devices in radiology Radiology 205 1997 27 36
6. Federal Food, Drug, and Cosmetic Act, Sect 906.
7. SL Nightingale Investigational use of marketed products 1982 Sep 1 Food and Drug Administration
8. RJ Sheretz SA Streed Medical devices: significant risk vs nonsignificant risk JAMA 272 1994 955 956
9. JR Less S Alpert SL. Nightingale Institutional Review Boards and medical devices JAMA 272 1994 968 969
10. 21 CFR Sect 812.2(b).
11. Guidance on the review of investigational device exemptions (IDE) applications for feasibility studies IDE Guidance Memorandum No. #D89-1 1989 May 17
12. 21 CFR Sect 812.27.
13. 21 CFR Sect 812.25.
14. 21 CFR Sect 812, subpart B.
15. 61 FR 48417-48425 (1995).
16. 42 CFR Sect 405, subpart B.