CDRH New Update

The following new items were added to the CDRH web pages on October 24, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• 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
• FDA Voice Blog: Medical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval
• Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
• Federal Register: Breakthrough Devices Program
• Federal Register: Deciding When To Submit a 510(k) for a Change to an Existing Device 
• Federal Register: Deciding When To Submit a 510(k) for a Software Change to an Existing Device 
• Federal Register: In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies, and Clinical Drug Interaction Studies--Study Design, Data Analysis, and Clinical Implications