The FDA's perspective on clinical laboratory devices. The premarket review and evaluation process.
Aziz
K J
KJ
Div. of Clinical Laboratory Devices, Food and Drug Administration, Rockville, MD 20857, USA.
Sliva
C A
CA
Gutman
S I
SI
D002624:Chemistry, Clinical / Q000295:instrumentation*; D004869:Equipment Safety; D005188:False Negative Reactions; D008389:Marketing of Health Services; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*