AdvaMed, in partnership with Hogan Lovells, will host a webinar that will explore the essentials of AI-based technology in FDA marketing submissions.

The discussion will highlight best practices and common pitfalls, drawing on extensive practical experience in drafting submissions for AI-based medical devices. It will also examine specific requirements and data necessary for support, including a focused look at the FDA’s recent guidance on predetermined change control plans (PCCP).

Presenters Kelliann Payne, partner at Hogan Lovells, and Alex Smith, director of regulatory sciences, global regulatory, Hogan Lovells, will address the critical elements of marketing submission for AI-based devices, emphasizing algorithm training and software requirements.

Access more information and register for the February 23 session at 11:30 a.m. ET via AdvaMed’s website.