On January 18, Foley partner Kyle Faget, co-chair of the firm’s Medical Device & Equipment Area of Focus is speaking at the upcoming Strafford webinar titled “AI in Cutting-Edge Medical Devices: PCCPs in Marketing Submissions, Streamlining FDA Approval Process.” This CLE webinar will guide health care practitioners through the U.S. Food & Drug Administration’s (FDA) approval process for artificial intelligence (AI) medical devices including Software as a Medical Device (SaMD) and the attempts by the FDA to streamline the regulatory process. The panel will discuss the FDA’s recent draft guidance related to using predetermined change control plans (PCCPs) in marketing submissions, including drafting considerations, how PCCPs may streamline the FDA approval process, and best practices for using PCCPs.
The panel will review these and other important issues:
- What software qualifies as a medical device requiring FDA approval?
- How is the FDA attempting to streamline the medical device approval process to accommodate the advent of AI?
- What is the status of the current regulatory framework for FDA approval of SaMD?
- How can practitioners use PCCPs in market submissions?
This 90-minute webinar is eligible in most states for 1.5 CLE credits.