The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence.

The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the FDA intends to take, which include:

  • Further developing the proposed regulatory framework, including issuing draft guidance on a predetermined change control plan;
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.

AI/ML-based SaMD is a rapidly progressing field and the FDA anticipates this action plan will continue to evolve. The FDA welcomes continued feedback in this area and looks forward to engaging with stakeholders on these efforts. We will also continue to collaborate across the FDA to build a coordinated approach in areas of common focus related to AI/ML.

Click here to read the action plan: https://www.fda.gov/media/145022/download?utm_medium=email&utm_source=govdelivery

About the Digital Health Center of Excellence

Launched in September 2020 and located in the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. The goal of the Digital Health Center of Excellence is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

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