Update on FDA regulation of in vitro diagnostic devices.
Gutman
S
S
Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. sig@cdrh.fda.gov
Richter
K
K
Alpert
S
S
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