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May 5, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 4, 2023. To view listings for other dates, see CDRH New - News and Updates.

• Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
• New Emergency Use Authorizations
  • SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay (Drexel University College of Medicine)
  • Global Direct RT-PCR Test (Access Medical Laboratories, Inc.)
• Revised Emergency Use Authorizations
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC)
• Updated Emergency Use Authorizations
  • InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
• Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1
• Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
• VICTRE: In Silico Breast Imaging Pipeline
• Endoscope Geometric Distortion- A Method for Quantitative Evaluation (Updated)
• Infrared Thermographs- Methods for Evaluating Laboratory Performance (Updated)
• Method for Estimating the Likelihood of Wireless Coexistence (Updated)
• Modified Dot-Blot Method to Evaluate Personal Protective Equipment (PPE) (Updated)
• Verification Test Problems for Cardiac Electrophysiology Modeling Software (Updated)