Primer on medical device regulation: Part II. Regulation of medical devices by the U.S. food and drug administration

Radiology

Volumn 205, Issue 1, 1997, Pages 10-18

  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; EMERGENCY HEALTH SERVICE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; LAW; MARKETING; PRIORITY JOURNAL; RADIOLOGY; REVIEW;

EID: 0030762245     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiology.205.1.9314953     Document Type: Review

References (3)

1. Division of Small Manufacturers Assistance Office of Training and Assistance. Regulatory requirements for medical devices: a workshop manual. Rockville, Md: Food and Drug Administration, 1992; 4-4.
2. Office of Surveillance and Biometrics, Systems Division of Surveillance. Medical device reporting: an overview. Rockville, Md: Food and Drug Administration, 1996.
3. Office of Health and Industry Programs, Lowe N, Scott WL. Medical device reporting for user facilities. Rockville, Md: Food and Drug Administration, 1996.