On January 6, 2025, the US FDA published draft guidelines for developers of AI-based medical devices to strengthen the safe and efficient development and commercialization of these tools throughout their product lifecycles.
If finalized, these guidelines will be the first of their kind to incorporate comprehensive recommendations for the design, development, maintenance and documentation of these devices. By prioritizing FDA considerations”Total product lifecycle for medical devices“, the new draft guidance is designed to complement the recently finalized guidance on predetermined change control plans for AI and machine learning-based medical devices.
The finalized guidance includes recommendations for how developers can proactively plan device updates once the product is already in the market.
This week’s draft guidance outlines the FDA’s current thinking on how to address issues such as bias and transparency throughout the lifecycle of AI-based devices, particularly in the context of risk management.
To this end, the guide provides recommendations to help developers demonstrate how they assessed each tool for risks of bias. Additionally, the guidelines provide information on how and when developers should describe post-market performance monitoring and management of their AI-enabled devices in marketing submissions.
“The FDA has authorized more than 1,000 AI-enabled devices through established pre-market pathways. As we continue to see exciting developments in this area, it is important to recognize that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, Director. of the Center of Excellence in Digital Health within the Center for Devices and Radiological Health of the FDA, in a press release. “(This) draft guidance brings together relevant information for developers, shares lessons learned from authorized AI-enabled devices, and provides an initial point of reference for specific recommendations that apply to these devices, from the first development stages up to the entire life of the device.
The FDA is seeking public comment on this draft guidance by April 7, 2025, with a specific request for comment on the draft’s alignment with the AI lifecycle, the extent to which its recommendations address the concerns about emerging technologies such as generative AI, its approach to performance monitoring for AI-enabled devices and how information about these devices should be transmitted to users.
Alongside this draft guidance, the agency also recently released recommendations on using AI to support drug developmentin addition to advice on including tissue biopsies in clinical trials and improve the accuracy of pulse oximeters for all skin tones.
Shania Kennedy has been covering news related to healthcare IT and analytics since 2022.