CDRH New - July 1, 2021

If your email program has trouble displaying this email, view as a webpage. July 1, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 30, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Tidal Medical Technologies LLC, InSee Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Historical Information about Device Emergency Use Authorizations (Updated) Personal Protective Equipment EUAs (Updated) FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic (Updated) Importing Medical Devices During the COVID-19 Pandemic (Updated) Considerations for Selecting Respirators for Your Health Care Facility (Updated) Manufacturing and Distributing Respirators for Health Care Personnel Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic (Updated) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180040, DEN180067, DEN190016 and DEN190026 added) Transcript added to Virtual Public Workshop - Orthopedic Device Postmarket Review - June 10, 2021

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