Primer on medical device regulation: Part III. Regulatory mechanisms and import/export regulation

Radiology

Volumn 205, Issue 1, 1997, Pages 19-25

  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; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; JAPAN; LAW; MARKETING; PRIORITY JOURNAL; PUNISHMENT; RADIOLOGY; REIMBURSEMENT; REVIEW; UNITED STATES;

EID: 0030778902     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiology.205.1.9314954     Document Type: Review

References (7)

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2. FDA Drug Bull, April 1982.
3. Kessler DA, Pape SM, Sundwall DN. The federal regulation of medical devices. N Engl J Med 1987; 317:357-366.
4. McGivney WT, Hendee WR. Regulation, coverage, and reimbursement of medical technologies. Int J Radiat Oncol Biol Phys 1990; 18:697-700.
5. Sisk JE. The financing and regulation of medical devices in the United States. Med Prog Technol 1982; 9:181-186.
6. Vladeck B. Medicare expands coverage of investigational devices. JAMA 1995; 274:1186.
7. Gallivan M. The 1997 global medical technology update: the challenges facing U.S. industry and policy makers. Washington, DC: Health Industry Manufacturers Association, 1997.