CDRH New - April 29, 2022

U.S. Food and Drug Administration sent this bulletin at 04/29/2022 08:43 AM EDT

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U.S. Food and Drug Administration - CDRH New

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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