CDEReCATS, CDRH Emergency Use Authorizations
WHAT: New electronic system to request a Certificate of Pharmaceutical Product (CPP) online as an alternative to a paper submission
WHO: CDER
WHY: Possible reduction in certificate processing time, a guided step-by-step application process, real-time validation of data, and e-mail notifications of status updates
HOW: Electronic submission procedures guide
WHAT: Listing of current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices
WHO : CDRH
WHY: To diagnose and respond to public health emergencies