CDRH Industry Basics Workshop

The workshop will feature five topics, each of which will consist of a presentation and a Q&A session with a panel of experts. Participants will be encouraged to ask questions during each session. Topics include IDE, 510(k), DeNovo, CAPA and eMDR. 10:00 - 11:00 am Investigational Device Exemption Program 11:00 - Noon 510(k) Program Noon - 1:00 am De Novo Program 1:00 - 2:00 pm Lunch Break 2:00 - 3:00 pm. Corrective and Preventive Actions 3:00 - 4:00 pm. Medical Device Reporting and eMDR