U.S. Food and Drug Administration and regulation of medical devices in radiology

Radiology

Volumn 205, Issue 1, 1997, Pages 27-36

  Pritchard Jr , William F ^a,b   Carey, Ronald F ^a  

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

^b Food Drug Admin's Ctr Devices R   (United States)

Author keywords

Breast, US; Diagnostic radiology; Radiology and radiologists, socioeconomic issues; U.S. Food and Drug Administration

Indexed keywords

APPARATUS; BREAST BIOPSY; COMPUTER ASSISTED TOMOGRAPHY; DEVICE; DIAGNOSTIC IMAGING; ECHOGRAPHY; FOOD AND DRUG ADMINISTRATION; LAW; MARKETING; MEDICAL INSTRUMENTATION; NUCLEAR MAGNETIC RESONANCE IMAGING; PACKAGING; PORTOSYSTEMIC ANASTOMOSIS; PRIORITY JOURNAL; RADIODIAGNOSIS; REVIEW; SAFETY; SOCIOECONOMICS; STENT; VENA CAVA FILTER;

EID: 1842292768     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiology.205.1.9314955     Document Type: Review

References (24)

1. Shawker TH. FDA issues premarket approval. In: Society of Radiologists in Ultrasound Newsletter. Philadelphia, Penn: Society of Radiologists in Ultrasound 1996; 4(4):4-5.
2. Kopans DB. Recent issues in breast cancer detection and the premarket approval by the Food and Drug Administration of a US system for breast lesion evaluation: what happened to science? Radiology 1997; 202:315-316.
3. Schultz DG, Wagner RF, Campbell G. Science is alive and well at the Food and Drug Administration. Radiology 1997; 202:317-318.
4. U.S. Medical Technology Industry Fact Sheet, 1996. Washington, DC: Health Industry Manufacturers Association, 1997.
5. Study Group on Medical Devices, Cooper T (chairman). Medical devices: a legislative plan. Rockville, Md: U.S. Department of Health, Education and Welfare, 1970.
6. Christian CD. Maternal deaths associated with an intrauterine device. Am J Obstet Gynecol 1974; 119:441-444.
7. Culliton BJ, Knopman DS. Dalkon shield affair: a bad lesson in science and decision-making. Science 1974; 185:839-841.
8. Federal Food, Drug, and Cosmetic Act, §201(h).
9. Hendel PN. Bjork-Shiley strut fracture and disc escape: literature review and a method of disc retrieval. Ann Thorac Surg 1989; 47:436-440.
10. Federal Food, Drug, and Cosmetic Act, §513(a)(1)(C)(ii).
11. Federal Food, Drug, and Cosmetic Act, §515(c).
12. Office of Device Evaluation annual report fiscal year 1996. Washington, DC: U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1997.
13. 21 CFR §801.4.
14. Federal Food, Drug, and Cosmetic Act of 1938, §520(m).
15. 21 CFR §814, subpart H.
16. 62 Federal Register 16593 (1997).
17. Sheretz RJ, Streed SA. Medical devices: significant risk vs nonsignificant risk. JAMA 1994; 272:955-956.
18. Less JR, Alpert S, Nightingale SL. Institutional Review Boards and medical devices. JAMA 1994; 272:968-969.
19. 21 CFR §803.3(aa).
20. 61 Federal Register 60712-60713 (1996).
21. Nightingale SL. Investigational use of marketed products. Rockville, Md: U.S. Food and Drug Administration, 1982.
22. 61 Federal Register 37277-37278 (1996).
23. Shiffman ML, Jeffers L, Hoofnagle JH, Tralka TS. The role of transjugular intrahepatic portosystemic shunt for treatment of portal hypertension and its complications: a conference sponsored by the National Digestive Diseases Advisory Board. Hepatology 1995; 22:1591-1597.
24. Miller-Catchpole R. Transjugular intrahepatic portosystemic shunt (TIPS): diagnostic and therapeutic technology assessment (DATTA). JAMA 1995; 273:1824-1830.