On Tuesday, January 12, the U.S. Food and Drug Administration released an action plan on Artificial Intelligence/Machine Learning (AI/ML), the first of its kind, based on the use of software as a medical device (SaMD). The action plan outlines a multi-pronged approach to strengthen the Agency's oversight of AI/ML-based medical software.

The Food & Drug Administration, or FDA in the United States, has decided to trust Artificial Intelligence and Machine Learning as medical devices. The American agency announced on Tuesday 12 January this year a course of action in favour of AI and ML in the health field.


"This action plan outlines the FDA's next steps to advance surveillance of MDS. (Software as a Medical Device, editor's note) based on AI/ML"said Bakul Patel, Director of the Center for Digital Health Excellence at the Center for Devices and Radiological Health (CDRH). "The plan describes a holistic approach based on product lifecycle monitoring to further develop the enormous potential that these technologies have to improve patient care, while providing safe and effective software functionality that improves the quality of patient care. In order to stay current and address patient safety issues and improve access to these promising technologies, we expect this action plan to continue to evolve over time.".

A five-step action plan

The action plan for software as a medical device based on AI/ML describes five actions that the FDA intends to take:

1. Further develop the proposed regulatory framework, including issuing draft guidance on a pre-determined change control plan (for software learning over time) ;
2. Support the development of best practices for evaluating and improving machine learning algorithms ;
3. Promote a patient-centred approach, including transparency of devices to users;
4. Develop methods to evaluate and improve machine learning algorithms;
5. Promote real-world performance monitoring drivers;

AI becomes a SaMD

The AI/ML Action Plan is a response to stakeholder comments on the discussion paper "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device", published in April 2019.


The Food and Drug Administration (FDA) welcomed the continued feedback in this area and decided to pursue this effort with stakeholders. The Agency will also continue to work together to develop a coordinated approach in areas of common interest related to AI/ML.

Digital innovation to improve health

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


The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy and security of human and veterinary drugs, vaccines and other biological products for human use, as well as medical devices. The agency is also responsible for the safe and reliable supply of food, cosmetics, dietary supplements, electronic radiation products, and the regulation of tobacco products in our country.