Primer on medical device regulation: Part I. History and background

Radiology

Volumn 205, Issue 1, 1997, Pages 1-9

  Monsein, Lee H ^a  

^a WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

Radiology and radiologists; State of art reviews; U.S. Food and Drug Administration

Indexed keywords

DEVICE; FOOD AND DRUG ADMINISTRATION; LAW; MARKETING; MEDICAL TECHNOLOGY; PRIORITY JOURNAL; RADIOLOGY; REVIEW;

EID: 0030819041     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiology.205.1.9314952     Document Type: Review

References (8)

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2. Wholey M, Haller J. An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy. Cardiovasc Intervent Radiol 1995; 18:72-76.
3. O'Reilly J. Food and Drug Administration. Colorado Springs, Colo: Shepard's/ McGraw-Hill, 1993.
4. Merrill RA. Regulation of drugs and devices: an evolution. Health Aff 1994; 13:47-69.
5. Kaufman J. Medical device regulation in the United States: protecting the public or impeding progress. Semin Intervent Radiol 1995; 12:277-283.
6. Gallivan M. The 1997 global medical technology update: the challenges facing U.S. industry and policy makers. Washington, DC: Health Industry Manufacturers Association, 1997; 37-51.
7. Forces reshaping the performance and contribution of the U.S. medical device industry. New York, NY: Wilkerson Group, 1995; 3-31.
8. Harkin D, Beall A. Excerpts and summary of a National Conference on Medical Devices: Bethesda, Md, September 6-7, 1969. JAMA 1969; 210:1745-1751.