CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 15, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 14, 2020. To view listings for other dates, see CDRH New - News and Updates.

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System - P200015
• Recognition and Withdrawal of Voluntary Consensus Standards - Guidance for Industry and Food and Drug Administration Staff
• Webinar - Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance - October 15, 2020
• Digital Health Software Precertification (Pre-Cert) Program (Updated)
• Class I Recall: Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys
• Class I Recall: Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame
• 3rd Quarter FY 2020 MDUFA IV Performance Report
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Recognition and Withdrawal of Voluntary Consensus Standards