CDRH New Update

The following new items were added to the CDRH web pages on June 12, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication Meeting materials posted for June 14, 2018 Anesthesiology and Respiratory Therapy Devices Panel Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff Federal Register: Humanitarian Device Exemption Program