FDA's new regulatory paradigms for in vitro diagnostic devices.

Robinowitz, M

FDA's new regulatory paradigms for in vitro diagnostic devices. [electronic resource] - Cytotherapy 1999 - 353-7 p. digital

Publication Type: Journal Article

1465-3249

10.1080/0032472031000141278 doi


Device Approval--legislation & jurisprudence
Equipment and Supplies--standards
Government Regulation
Humans
Reagent Kits, Diagnostic--standards
United States
United States Food and Drug Administration--organization & administration