FDA Issues Final Guidance on Marketing Submission for AI-Enabled Device Software Functions
Dec. 4, 2024
On Dec. 3, the FDA posted the final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
The guidance, according to an announcement, is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices.
Further, the guidance provides recommendations on the information to include in a predetermined change control plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs).
Additionally, on Jan.14, 2025, the FDA will host a webinar on the final guidance.
Janette Wider is Editor-in-Chief for Healthcare Purchasing News.
