FDA Medical Device Submissions in a Changing Regulatory Landscape, Including 510(k) and Denovo Process

Much attention has been focused on the EU MDR regulation recently, but the U.S. regulatory landscape has not remained stagnant. Over the past year, FDA has proposed many sweeping changes to the 510(k) device submission process as part of their Medical Device Safety Action Plan initiative. FDA hopes these changes will encourage innovation amongst medical device manufacturers to meet the needs of patients with advancements in technology, safety, and efficacy. For medical device manufacturers, understanding and incorporating these changes into their new product development and regulatory strategy discussions increase the opportunity for commercial clearance in the United States

The best path forward for commercial distribution in the United States is one of the fundamental challenges for any medical device manufacturer. Over the past year, the U.S. FDA has proposed and implemented sweeping changes to modernize the most utilized regulatory path for commercial clearance - the 510(k) device submission process. The FDA’s initiatives include: limiting devices that can be used as predicates, expansion of the abbreviated 510(k) pathway, moving selected pre-submission obligations to post-market, clarity on the use of De Novo designation, a push for wider adoption of Pre-submission (or Q-Sub) meetings with the FDA prior to and during device submission, and CDRH reorganization. This session will take a deeper dive into how these measures create more efficient regulatory pathways for medical device manufacturers to bring innovative technology to the U.S. market by understanding and incorporating the FDA’s thinking into their new product and regulatory strategy development in order to stay ahead of the changing regulatory landscape. This session will highlight the best practices for interactions with the FDA before, during, and after the medical device submission process.