New guidances outline eSTAR submission requirements for de novo and 510(k) device applications
Regulatory NewsMichele G. Sullivan
Diagnostics/IVDsMedical DevicesNorth AmericaRegulatory Intelligence/PolicyUnited StatesRegulatory NewsMichele G. SullivanDiagnostics/IVDsMedical DevicesNorth AmericaRegulatory Intelligence/PolicyUnited States