The FDA has introduced draft guidance to assist developers of AI-enabled medical devices with regulatory submissions and life cycle management. This includes detailed recommendations for design, development, testing, ongoing monitoring, and strategies to address transparency and mitigate bias risks in AI systems.
The guidance aims to ensure that AI-powered devices in healthcare are safe, effective, and equitable for all users. Public comments on the draft are open until April 7, with the FDA hosting webinars to discuss the proposals and clarify its regulatory approach. This initiative reflects the FDA’s commitment to supporting innovation while addressing the unique challenges of AI in medical devices.
Source: www.healthcareitnews.com/news/fda-offers-new-draft-guidance-developers-ai-enabled-medical-devices
