Doctors Wary of Medical AI Devices U.S. regulatory system criticized for approving AI medical devices without transparency.

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Chart showing the number of AI/ML devices approved by FDA by year from 2012 to 2023

The United States’ regulatory regime may not be clear or flexible enough to ensure the safety of AI-powered medical devices.

What’s new: Physicians and other health professionals believe that U.S. regulators have approved AI-powered medical products without proper oversight or disclosure, according to a report by The New York Times. The FDA had approved roughly 700 products as of July 2023.

How it works: The Food and Drug Administration (FDA) approves medical devices and diagnostic systems in the U.S. It approves almost all such products that involve AI through a program known as 510(k).

  • Established in 1976, this streamlined program was designed to regulate devices like pacemakers and X-ray machines. It has not been updated for modern machine learning and data science. 
  • Unlike the approval process for drugs, the path for devices doesn’t require clinical trials, except in cases where the devices support or pose a risk to human life. Instead, manufacturers must demonstrate that their products are as safe and effective as previously approved products, typically by meeting similar benchmarks. Some medical professionals believe that this backward-looking orientation is especially ill-suited to AI. For example, large language models such as Google’s Med-PaLM 2 aren’t directly comparable to earlier medical-reference products.
  • The FDA doesn’t require makers of AI-powered medical products to disclose important information such as how an AI product was built or how many people it was tested on. Consequently, medical professionals may not be able to judge whether a product is appropriate in any given case.

What they’re saying: “If we really want to assure that right balance, we’re going to have to change federal law, because the framework in place for us to use for these technologies is almost 50 years old.” — Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA

Behind the news: The FDA’s approval of AI-enabled medical products has been contentious. 

  • In early 2021, healthcare news outlet Stat News surveyed 161 products approved between 2012 and 2020. Only 73 of their makers had disclosed the number of patients the product was tested on, and fewer than 40 had disclosed whether their training or test data came from more than one facility, which is an important indicator of whether a device’s performance is reproducible. 
  • Last year, the FDA issued guidance that clarified which AI systems require approval as medical devices. However, the clarification didn’t significantly change the approval process, leading to calls to change the requirements.

Why it matters: In medicine, the right tool can be a life saver, while the wrong one can be fatal. Doctors need to have confidence in their tools. The current FDA process for AI-powered medical products makes it hard to separate what works from what doesn’t, and that’s delaying adoption of tools that could save lives.

We’re thinking: We have great faith that AI can improve medical care, but we owe it to society to document efficacy and safety through careful studies. Machine learning algorithms are powerful, but they can suffer from data drift and concept drift, which leads them to work in experiments but not in practice. Updated standards for medical devices that are designed to evaluate learning algorithms robustly would help point out problems, help developers identify real problems and solutions, and give doctors confidence in the technology.


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