🎤 John E. Lincoln | 📅 October 23, 2024 | 🕒 11 AM Eastern Time US
Description:
This webinar will explore the FDA’s recent initiatives aimed at streamlining the approval process for innovative and safer medical technologies. These include the Medical Device Safety Action Plan and updates to enhance the 510(k) and De Novo review processes, creating more efficient pathways for novel devices to gain FDA clearance or approval.
Additionally, the FDA has introduced two new programs: the finalization of guidance for the Breakthrough Device Program and the development of the Safer Technologies Program (STeP). Both programs focus on 510(k) and PMA pathways, offering less restrictive submission requirements for breakthrough technologies. This shift in the FDA’s approach prompts the industry to rethink submission strategies to take advantage of these new opportunities.
Why You Should Attend:
In recent years, the FDA has actively modernized the 510(k) clearance pathway, primarily used for low- to moderate-risk devices that are substantially equivalent (SE) to existing market products. The updates, outlined in the 2018 Medical Device Safety Action Plan, create new opportunities for devices to be cleared more efficiently, especially for breakthrough technologies or safer devices that reduce risks for users. By expanding flexibility for SE comparisons, these pathways allow manufacturers to clear advanced devices without needing to pursue the more demanding De Novo or PMA submissions.
Who Should Attend: