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