Business · 20/12/2011
FDA Releases Guidance on Enforcement of Premarket Notification Requirements for In Vitro Diagnostic and Radiology Devices
The Food and Drug Administration (FDA) has announced the availability of a guidance document outlining its enforcement policy for premarket notification requirements for certain in vitro diagnostic and radiology devices, as mandated by regulations.
Original source language: Federal Register — Health and Human ServicesOpen original release →