Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
After Yes - Navigating the Rules of the Road in Today's Marketplace
Regulatory, Quality and Good Manufacturing Practices
Advances in software and data technologies have forced the FDA to reimagine its approach to regulating these products. This panel will explore the Agency’s current plan to restructure its software regulations through its pre-certification pilot program and the Agency’s proposal to regulate artificial intelligence. Panelists will offer insights into how companies developing medical software are positioning themselves to take advantage of these proposals and other regulatory challenges they face.