FDA Releases Plan to Regulate AI/ML Software

Artificial Intelligence (AI) and Machine Learning (ML) software are a reality for medical device development and use. How the FDA will regulate the technology is critically important to device makers.

On January 12, 2021, the FDA released the first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This plan describes a "multi-pronged approach to advance the agency’s oversight of AI/ML-based medical software."

The plan comes after public input from an April 2019 discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.

We reported on this paper in July 2019.

The AI/ML Regulatory Challenge

At issue was how the agency would regulate AI/ML used in software and how it would keep track of ongoing changes to such software to ensure that any changes are safe and effective, without requiring an entirely new submission for each iteration of the software.

Simply put, AI algorithms are software that can learn from and act on data. But what if that data changes the safety profile of the device? Does the manufacturer have to go back for another clearance or approval?

At the time, the FDA does not take into consideration the continued adaptation of SaMDs using AI/ML.

Action Plan

Here are the five actions the FDA intends to take, including:

• “Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time).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

Bakul Patel, is the director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). The Center was launched in September 2020. Patel said 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.”