View the 2025 510(k) and De Novo program below or download it here.
| The Law and Regulations Sally Maher, Regulatory Consultant, Sally Maher Consulting – 510(k) definition – 510 and 513 FDCA – Guidance for 510(k): general & product specific – How to find it – How to use it – Different types of 510(k)s; which to use – Review of bundling 510(k)s – FDA Product Codes – Activity |
| 510(k) Strategy and Planning Tony Blank, Senior Director of Regulatory Affairs, AtriCure – Staff involved – Role of each function – RA responsibilities – Use of guidance – Global considerations – Pre-submissions – Predicates – Breakthrough Devices Program – Safer Technologies Program |
| Preparing the Submission Jemin Jay Dedania, Senior Director of Regulatory Affairs and Compliance at the National Evaluation System for health Technology, MDIC Melissa Hall, Founder and Principal Consultant, Statera Regulatory Consulting – General information including how to select a predicate device – Assembling the 510(k) – eCopy – eSTAR |
| The FDA Review Process Alexia Haralambous, Senior Principal, RQM+ – How it works at FDA – FDA/industry interactions – Refuse to Accept – Submission Issue meetings – FDA holds – Interactive review – Least Burdensome flag – Current pilots |
| Clearance: Launch and After Tony Blank, Senior Director of Regulatory Affairs, AtriCure – What clearance does and does not mean – Promotional practices for 510(k) devices – FDA – FTC – Complaint Handling and MDRs – When to File a New 510(k) for Device Modifications – Catch-up 510(k)s |
| De Novo Elaine Tseng, Partner, King & Spalding – Definition of a De Novo – Final Rule on De Novo – When De Novo is used – Differentiation from 510(k) |
| Regulatory Strategy for De Novo Ginny Hu, Director, Regulatory Affairs, Dexcom – Key eligibility criteria – Benefit-risk analysis |
| Preparing the De Novo Submission Bryan Osborne, Senior Manager, Regulatory Affairs, Dexcom – Content – Assembling the submission |
| FDA Review Process for De Novo Elaine Tseng, Partner, King & Spalding – Use of Pre-Submission meeting – Rationale for De Novo – Clinical Protocols – Special Controls |
| Maintenance of a Granted De Novo Laura Rose, PhD, Engagement Partner, Bruder Consulting & Venture Group – Post-market requirements – Classification Order – De Novo database, granting order, decision summary – Use as a predicate – Making changes to granted De Novo device |
| Applied Learning and Breakout Discussions* Tony Blank, Senior Director of Regulatory Affairs, AtriCure *In person participants, only – 510(k) & De Novo Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies & Key Takeaways – Regroup for Q&A |
