The US Food and Drug Administration (FDA) has issued a draft guidance for Developers of Artificial Intelligence-Enabled Medical Devices.

If finalized, this will be the first guidance to provide comprehensive recommendations for AI medical devices, offering their creators an accessible set of considerations that promote the safety and effectiveness of the devices.

This guidance aligns with the FDA’s commitment in promoting safe and effective innovations in the sector, and it has also issued preliminary guidance on the use of AI in the development of drugs and biological products.

Artificial Intelligence and the medical device market

In the United States, the number of medical devices with artificial intelligence has increased significantly over the last decade.

The FDA has already approved more than 1,000 devices based on AI or machine learning, and has also seen a huge increase in new product submissions.

In academia, studies are being carried out on the importance of analyzing the regulatory frameworks of the main regulatory bodies, focusing on the implementation of international standards and global safety protocols.


Recommendations for Post-Market Monitoring and Risk Management

The draft guidance outlines recommendations on:

  • How and when sponsors should describe monitoring in submissions.
  • Managing the post-market performance of AI-powered devices.

 

The proposed recommendations reflect a comprehensive approach to risk management throughout the entire lifecycle of the device.

The FDA encourages sponsors to engage with the agency early on and use this guidance, once finalized, to inform their activities throughout the device lifecycle, including:

  • Planning,
  • Development,
  • Testing,
  • and continuous monitoring stages.

Transparency, Trends, and Public Feedback

This draft guidance also includes the FDA’s strategies for addressing transparency and trends throughout the lifecycle of AI-powered devices.

Additionally, until April 7, 2025, the FDA is inviting public comments on this draft guidance, with a particular focus on the following questions:

  • The adequacy of the guidance concerning the AI lifecycle.
  • The guidance’s ability to address concerns related to emerging technologies like generative AI.
  • The approach to performance monitoring (including the use of monitoring plans as a risk mitigation strategy for AI-powered devices).
  • The type of information about AI-powered devices that should be provided to users and the best way to deliver it.

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