CDRH New Update

The following new items were added to the CDRH web pages on November 27, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• Pediaric X-ray Imaging
• Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff
• Webinar - Pediatric Information for X-ray Imaging Device Premarket Notifications: Final Guidance - January 9, 2018
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170017 added)
• Federal Register: Pediatric Information for X-ray Imaging Device Premarket Notifications
• Federal Register: Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop