FDA finalizes AI-enabled medical device guidance

On Dec. 4, 2024, the U.S. FDA issued finalized recommendations to simplify the process for approving AI- and machine learning-enabled medical devices.

The guidance comes as nearly 1,000 AI/ML-enabled devices have already been approved by the agency, with many of those approvals spiking in recent years.

The influx of AI/ML-powered medical devices is a testament to the hype the technologies have generated in healthcare and life sciences industries, as the tools have demonstrated promise in improving care and reducing administrative burdens.

However, making sure that AI-enabled medical software is both safe and effective presents hurdles for both device manufacturers and regulatory bodies.

The FDA guidance, a draft of which was published last year, "is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices," according to the memo.

The memo indicated that the development of AI-enabled medical devices is iterative, and the FDA's recommendations are designed to be "least burdensome" for tool developers to support small, steady improvements while prioritizing device effectiveness and safety.

To this end, the guidelines -- which are nonbinding recommendations -- outline that AI developers can seek approval to modify their devices without being required to file additional submissions to demonstrate the tool's safety and efficacy.

Further, the guidance recommends that AI-enabled medical device manufacturers submit a marketing approval application along with a plan detailing any modifications to be made and how those changes will be evaluated.

The recommendations also direct device developers to include descriptions of any planned changes to the tool, the testing necessary to ensure safety and effectiveness, and a risk mitigation strategy within a Predetermined Change Control Plan (PCCP).

"This guidance recommends that a PCCP describe the planned [AI-enabled device software function] modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP," the memo states.

Shania Kennedy has been covering news related to health IT and analytics since 2022.