CDRH New Update

The following new items were added to the CDRH web pages on November 9, 2018. Previous CDRH New items can be found on the CDRH New webpage. Presentation and Transcript added to: Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018 Emergency Use Authorization: DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.) Press Release: FDA authorizes emergency use of first Ebola fingerstick test with portable reader