CDRH New - January 29, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 28, 2020. To view listings for other dates, see CDRH New - News and Updates.

Class I Recall: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve Ethylene Oxide Sterilization Facility Updates Public Meeting - Food and Drug Administration’s Communications About the Safety of Medical Devices - April 1, 2020 Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180014 and DEN180058 added)