Are current regulations for approval of in vitro diagnostic devices adequate?
Levine
D
D
New England Pediatrics, Limited Liability Partnership, Stamford, CT 06902, USA. ARosen45@aol.com
Grossberg
R
R
Tilton
R
R
Banks
P
P
Rosenfeld
A
A
D018795:Device Approval / Q000331:legislation & jurisprudence*; D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration
D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic