The FDA outlines draft guidance on AI for medical devices

The agency also published draft guidance on the use of AI in drug development

AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at $10.31 billion in 2023, is forecasted to reach $14.92 billion in 2024 and then $164.16 billion by 2030, growing at a compound annual growth rate (CAGR) of 49.1%.

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug Administration (FDA) has unveiled a new draft guidance on AI-enabled devices, including recommendations to support development and marketing to make them  "safe and effective" throughout the device’s Total Product Life Cycle (TPLC).

The draft guidance includes recommendations for how and when sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices in their marketing submissions. It also encourages sponsors to engage with the FDA early and often, and to use this used the finalized guidance to guide their activities throughout the life cycle of the device, including during planning, development, testing and ongoing monitoring.

The TPLC approach provides staff at the Center for Devices and Radiological Health (CDRH), the center in the FDA that regulates medical devices, with views into device development through commercialization, so they can guide device decision-making, both before and after they are on the market.

TPLC also helps the FDA respond to safety issues, makes sure there's transparency on device safety and performance throughout the device's life cycle, and allows CDRH to provide  internal and external customer service.

“The FDA has authorized 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, said in a statement. 

“Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific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.”

In addition to the draft guidance on AI-enabled devices, the FDA also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products.

"In recent years, the use of AI in the drug product life cycle has increased. Continuous advancements in AI hold the potential to accelerate the development of safe and effective drugs and enhance patient care. Concurrent with these technological advancements, the use of AI in regulatory submissions to FDA has also increased for some uses," the FDA wrote. 

"However, AI use presents some unique challenges. First, the variability in the quality, size, and representativeness of datasets for training AI models may introduce bias and raise questions 88 about the reliability of AI-driven results. As such, data used to develop AI models should be fit for use, which means the data should be both relevant (e.g., includes key data elements and sufficient numbers of representative participants or sufficient data that is representative of the manufacturing process or operation) and reliable (i.e., accurate, complete, and traceable)." 

The FDA is requesting public comment on this draft guidance by April 7, as well as public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the approach to performance monitoring, including use of a performance monitoring plan as a means of risk mitigation for AI-enabled devices; the type of information about AI-enabled devices that should be conveyed to users; and the most appropriate approach to deliver that information.

The FDA will also hold a webinar on February 18 to discuss the draft guidance.

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