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December 19, 2023

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

• Federal Register: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• CDRH learn (Updated)
  • Presentation and Transcript for Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling - December 5, 2023
• Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
• Total Product Life Cycle Advisory Program (TAP) (Updated)
• Recognized Consensus Standards Database (Updated)