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May 19, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 18, 2023. To view listings for other dates, see CDRH New - News and Updates.

• Reissued Emergency Use Authorization
  • DTPM COVID-19 RT-PCR Test - (DTPM, Inc.)   
• Revised Emergency Use Authorization
  • Status COVID-19/Flu A&B (Princeton BioMeditech Corp.) 
  • BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (Becton, Dickinson and Company (BD)
• Updated Emergency Use Authorizations
  • Nano-Check COVID-19 Antigen At-Home Test (Nano-Ditech Corporation)
• Consumer Information: Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (serafilcon A) - P220007 (Alcon Laboratories, Inc.)
• Consumer Information: MiniMed 780G System - P160017/S091 (Medtronic MiniMed, Inc.)
• Meeting Notice: September 6, 2023 Patient Engagement Advisory Committee