January 18, 2021
The agency outlines approach to medical products that change over time
The US Food and Drug Administration (FDA) has issued its first AI/ML action plan to advance the oversight of artificial intelligence and machine learning-based medical software.
The AI/ML-based software as a medical device (SaMD) plan details various actions the FDA intends to take, including continuing development of the planned regulatory framework.
“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,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health.
“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.”
Algorithm Change Protocol
The action plan follows feedback from stakeholders, after a paper with the proposed regulatory framework was published in April 2019.
The plan creates draft guidance for software that is able to learn over time and calls for the development of “good machine learning practices to evaluate and improve machine learning algorithms.”
The FDA also intends to advance real-world performance monitoring pilots, and foster a patient-centered approach, encouraging device transparency to users.
For SaMD, manufacturers already have to submit an application to the FDA before distributing their device.
The current guidance envisions a “predetermined change control plan” in premarket submissions. This plan would describe the types of anticipated modifications involved in ML algorithms, and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients —referred to as the “Algorithm Change Protocol.”
“This approach could allow for the FDA’s regulatory oversight to embrace the iterative improvement power of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety,” the agency stated.
In this potential approach, the FDA would expect a commitment from manufacturers on transparency and real-world performance monitoring for artificial intelligence and machine learning-based SaMD.
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