The US FDA has launched an action plan to harness the “enormous potential” held by AI in the field of medical devices.

The plan details a multi-pronged approach through which the regulator will advance its oversight of AI and machine learning-based medical software.

It outlines five key actions the FDA will take – including further development of proposed regulatory frameworks, supporting the advancement of good machine learning practices and fostering a patient-centred approach.

Bakul Patel, director of the Digital Health Center of Excellence in the FDA Center for Devices and Radiological Health (CDRH), said: “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based software as a medical device.

“The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care, while delivering safe and effective software functionality that improves the quality of care that patients receive.

“To stay current and address patient safety, and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”


New FDA AI action plan

In a statement, the FDA summarised the five actions it intends to take under its first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, which include:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan – for software’s learning over time
  • 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
  • Advancing real-world performance monitoring pilots


According to the FDA, the action plan is a response to stakeholder feedback received from an April 2019 discussion paper entitled Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.

It was set up and will be managed by the CDRH Digital Health Center of Excellence, which launched in September 2020 to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role.