New directions in the FDA regulation of in vitro diagnostic devices

Laboratory Medicine

Volumn 30, Issue 12, 1999, Pages 782-785

  Gutman, Steven ^a   Richter, Kimber ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ERROR; REVIEW;

EID: 0032749949     PISSN: 00075027     EISSN: None     Source Type: Journal    
DOI: 10.1093/labmed/30.12.782     Document Type: Review

References (7)

1. Pub L No. 94-295, Stat 539.
2. Pub L No. 52, Stat 1052.
3. US Food and Drug Administration. Premarket Notification 510(k) - Regulatory Requirements for Medical Devices. Rockville, Md: Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health; 1995. FDA Publication 95-4158.
4. Medical devices, current good manufacturing practices (cGMP) final rule: quality system regulation, 61 Federal Register 195 (1996).
5. Pub L No. 105-115, Stat 830.
6. Medical devices exempt from premarket notification, class II devices, Proposed rule, 63 Federal Register 59222 (1998).
7. Medical devices exempt from premarket notification and reserved devices, class I, Proposed rule, 63 Federal Register 63222 (1998).