The cover graphic from the FDA Action Plan report shows how AI/ML tech assists doctors and surgeons with identifying a lung anomaly.

FDA Releases Action Plan for Regulating AI/ML-based Medical Device Development

As President Biden continues to sign Executive Orders to rapidly address COVID issues facing the United States, another big change was already instituted earlier this month by the U.S. Food and Drug Administration (FDA). A plan on how to integrate AI and machine learning (ML) into the medical field was highlighted in an article from

Priya Dalani writes:

Last week, the U.S. Food and Drug Administration presented the organization’s first Artificial Intelligence/Machine Learning (AI/ML)- Based Software as a Medical Device (SaMD) Action Plan. This plan portrays a multi-pronged way to deal with the Agency’s oversight of AI/ML-based medical software.

The Artificial Intelligence/Machine Learning (AI/ML)- Based Software as a Medical Device (SaMD) Action Plan is a response to stakeholder input on the FDA’s 2019 regulatory structure for AI and ML-based medical items.

The FDA will hold a public workshop on algorithm transparency to work with stakeholders and partners and discuss other key activities, such as assessing predisposition in algorithms. The Action Plan proposes a guide for setting up a regulatory framework so that the FDA can encourage development and speed up approvals of AI-based medical technologies and those that rely on machine learning.

According to Bakul Patel, Director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH), “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD.”

He further adds:

“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.”

The AI/ML-Based Software as a Medical Device Action Plan plots five actions that the FDA expects to take, including:

• Further building up the proposed administrative system, including through the issuance of draft direction on a foreordained change control plan (for software’s learning after some time);

• Supporting the advancement of good machine learning practices to assess and improve ML algorithms;

• Cultivating a patient-focused methodology, including device transparency to clients;

• Creating techniques to assess and improve ML algorithms; and

• Propelling real-world performance monitoring pilots.

This is an important effort by the government to make the best use of AI and machine learning for better health care.