New directions in the FDA regulation of in vitro diagnostic devices

Authors
Gutman, S Richter, K
Citation
S. Gutman et K. Richter, New directions in the FDA regulation of in vitro diagnostic devices, LAB MED, 30(12), 1999, pp. 782-784
Categorie Soggetti
Research/Laboratory Medicine & Medical Tecnology
Journal title
LABORATORY MEDICINE
ISSN journal
00075027 → ACNP
Volume
30
Issue
12
Year of publication
1999
Pages
782 - 784
Database
ISI
SICI code
0007-5027(199912)30:12<782:NDITFR>2.0.ZU;2-6
Abstract
Since 1976, the Food and Drug Administration has been involved activity in the regulation of in vitro diagnostic devices. Regulation involves a series of premarket and postmarket controls designed to assure that tests meet mi nimum thresholds of performance and are labeled properly. The review progra m for medical devices recently has undergone a variety of changes to produc e more effective use of its regulatory tools.