CDRH New Update

The following new items were added to the CDRH web pages on October 2, 2017. Previous CDRH New items can be found on the CDRH New webpage. September 2017 PMA Approval List National Cybersecurity Awareness Month Has Arrived User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff New CDRH Learn Module - Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction