Update on FDA regulation of in vitro diagnostic devices

JAMA

Volumn 280, Issue 2, 1998, Pages 190-192

  Gutman, Steven ^a   Richter, Kimber ^a   Alpert, Susan ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE; DIAGNOSTIC TEST; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; PRIORITY JOURNAL; REVIEW; SAFETY;

EID: 0032496885     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.280.2.190     Document Type: Review

References (8)

1. Pub L No. 94-295, 90 Stat 539.
2. Pub L No. 101-629, 104 Stat 4523.
3. Pub L No. 102-300, 106 Stat 238.
4. Food and Drug Administration. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostics (IVDs): Guidance Regarding Premarket Submissions. Rockville, Md: Center for Devices and Radiological Health; 1988.
5. Medical Devices, Medical Device User Facility and Manufacturer Reporting, Certification and Registration, 60 Federal Register 237 (1995).
6. Medical Devices, Current Good Manufacturing Practice (CGMP) Final Rule: Quality System Regulation, 61 Federal Register 195 (1996).
7. Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing. Geneva, Switzerland: International Standardization Organization; 1994. Number 9001.
8. Pub L No. 105-115, 133 Stat 830.