CDRH New Update

The following new items were added to the CDRH web pages on November 29, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• Added Presentation and Transcript to Webinar - Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device" - November 16, 2017
• Federal Register: Exemption from Premarket Notification; Class II Devices; Surgical Apparel