The US Food and Drug Administration (FDA) has issued draft guidance on artificial intelligence (AI)-enabled medical devices.
The guidance outlines recommendations to ensure safe and effective development, marketing, and maintenance throughout the device’s total product life cycle.
If finalised, the guidance will represent the first comprehensive recommendations for AI-enabled devices across their entire lifecycle. It provides developers with clear guidelines on design, development, maintenance, and documentation to ensure safety and effectiveness.
The guidance also complements the FDA’s recently issued finalised recommendations on predetermined change control plans for AI-enabled devices, which help developers proactively plan for device updates after they enter the market.
FDA’s Center for Devices and Radiological Health, Digital Health Center of Excellence director Troy Tazbaz said: “As we continue to see exciting developments in this field, it’s important to recognise that there are specific considerations unique to AI-enabled devices.
“Today’s draft guidance brings together relevant information for developers, shares learnings from authorised AI-enabled devices and provides a first point-of-reference for specific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The draft guidance includes recommendations on how and when sponsors should include post-market performance monitoring and management in their AI-enabled device marketing submissions.
It provides a comprehensive approach to managing risk throughout the device’s lifecycle.
The FDA encourages early and continuous engagement with sponsors, advising them to use this guidance for activities such as planning, development, testing, and ongoing monitoring.
Additionally, the guidance highlights the FDA’s current stance on addressing transparency and bias throughout the lifecycle of AI-enabled devices.
It also outlines specific recommendations for mitigating bias risks and suggests strategies for the careful design and evaluation of AI-enabled devices.
The health regulator has also published new draft guidance to improve the accuracy and performance of pulse oximeters, vital devices used to measure blood oxygen levels.
The recommendations aim to improve pulse oximeter performance across skin tones by guiding manufacturers on clinical data collection, study design, and validation for accurate medical use.
Furthermore, the health agency, in collaboration with the Office for Human Research Protections, issued draft guidance to help industry, investigators, and review boards understand the considerations for including tissue biopsies in clinical trials for investigational products.
