The US Food and Drug Administration (FDA) has issued draft guidance that includes recommendations to support development and marketing of safe and effective artificial intelligence (AI)-enabled devices.
The guidance, if finalised, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices, a recent press release states. This guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.
“The FDA has authorised more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health. “The draft guidance brings together relevant information for developers, shares learnings from authorised AI-enabled devices and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle.”
The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the post market performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle. The FDA encourages sponsors to engage with the agency early and often, and to use this guidance, once finalised, to guide their activities throughout the life cycle of the device, including during planning, development, testing and ongoing monitoring.
Importantly, this draft guidance also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance describes specific recommendations intended to help a sponsor demonstrate they have addressed risks associated with bias and provides suggestions for the thoughtful design and evaluation of AI-enabled devices.
Notably, this announcement is specific to AI-enabled devices. This week, the FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products. The publication of the guidelines among other actions, continues to demonstrate the agency’s efforts to provide transparency and to help ensure product safety and effectiveness while supporting innovation in this rapidly growing field, the company states.
