CDRH New - April 29, 2022

If your email program has trouble displaying this email, view as a webpage. April 29, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 28, 2022. To view listings for other dates, see CDRH New - News and Updates. Digital Health Policies and Public Health Solutions for COVID-19 (Updated) At-Home OTC COVID-19 Diagnostic Tests (Updated) At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated) Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 20, 2022 Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users

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