TY  - GEN
AU  - Robinowitz,M
AU  - Gutman,S I
TI  - FDA's new regulatory paradigms for in vitro diagnostic devices
SN  - 1465-3249
PY  - 2010///0602
KW  - Device Approval
KW  - legislation & jurisprudence
KW  - Equipment and Supplies
KW  - standards
KW  - Government Regulation
KW  - Humans
KW  - Reagent Kits, Diagnostic
KW  - United States
KW  - United States Food and Drug Administration
KW  - organization & administration
N1  - Publication Type: Journal Article
UR  - https://doi.org/10.1080/0032472031000141278
ER  -