ISSUE

: The 510(k) process has been under scrutiny for its need to be more reflective of today’s technology standards. Regulatory reform has been prioritized to shift from a passive approach toward active surveillance. As part of this focus, the FDA established NEST, which relies on RWE for devices. Proposed reforms indicate additional post-market safety requirements for devices cleared via the 510(k) process. The FDA has selected women’s health as one of the focus areas for these regulatory reforms.

OVERVIEW

: This panel will debate the impact of RWE and proactive post-market surveillance on medical product innovation, patient access and safety. Jill Sackman will provide an overview of RWE, role of NEST, and regulatory changes in process. As the FDA has selected women’s health as a focus area, Dr. Shepherd, will discuss the impact of the proposed changes on patient safety, outcomes, and access to care and specifically impact to women in diverse/minority groups. Ms. Cohen, will discuss the impact of using RWE on patient safety as well as medical product liability that may be partially driving regulatory changes. She will address new liability issues that may arise as patient data are collected and used. Ms. Riley, will speak to the impact of changing predicate comparators and technology standards in the 510(k) process. She will address the cost/value of post-market data and the impact these changes may have on the speed with which innovative technologies reach the market. Each speaker will have 8 minutes. There will be 12-15 minutes of questions from the moderator to the panelists. Ten minutes will be left for questions from the audience.