FDA Issues Guidance for AI-Enabled Medical Devices

The FDA has issued draft guidance emphasizing the need for cybersecurity considerations in the development and lifecycle management of AI-enabled medical devices, which have seen over 1,000 approvals in recent years. This guidance aims to provide comprehensive recommendations throughout the total product lifecycle, addressing unique challenges faced by AI technologies. It encourages manufacturers to integrate cybersecurity measures in premarket submissions and postmarket performance monitoring. Additionally, the FDA's final guidance on Predetermined Change Control Plans allows manufacturers to implement pre-approved modifications for their AI devices without separate authorizations, streamlining the regulatory process. This approach supports ongoing improvements in a rapidly evolving field of healthcare technology. The draft guidance remains open for public comment until April 7.