FDA finalizes lifecycle plan guidance for AI-based medical devices
The US Food and Drug Administration (FDA) has announced the availability of its final guidance on AI-enabled medical devices.
The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – aims to provide a “forward-thinking approach to advancing the development of safe and effective AI devices,” the agency said in a statement. Tuesday.
WHY IT’S IMPORTANT
The guidelines provide recommendations on the information to include in a marketing submission for a device with one or more AI-enabled device software features. The FDA said changes to Artificial Intelligence-Enabled Device Software Functions, or AI-DSFs, expected over time will not require an entirely new market entry.
“Because changes specified and implemented in accordance with an authorized PCCP are reviewed and authorized through the marketing submission containing the PCCP, the changes can be implemented in the AI-DSF without the need for a new marketing submission,” the FDA said in his final guidelines posted in the Federal Register.
Instead, the agency said it will focus modification reviews “on the aspects of the device that have been most modified,” and suggested submitting documents detailing tracked changes.
According to the announcement, the agency will host a webinar on January 14, 2025 for industry and others to learn more about the final guidelines.
THE BIG TREND
The agency has said that while it is committed to deploying new devices faster, it will take a science-based approach to its requirements for medical devices powered by AI and ML.
The agency has considered how to avoid multiple submissions for technology that is expected to evolve and how to streamline the ongoing regulatory review process for developers throughout the life cycle of medical devices.
The draft guidance took into account performance related to race, ethnicity, disease severity, gender, age and geographic considerations in the ongoing development, validation, deployment and monitoring of AI/ML-enabled devices, said Brendan O’Leary , deputy director of the Digital Health Center of Excellence in the FDA’s Center for Devices and Radiological Health, in the agency’s March announcement opening a public comment period.
ON THE RECORD
“The recommendations in this guidance apply to AI-enabled devices, including the device component of device-controlled combination products, assessed through the 510(k), De Novo, and PMA pathways,” the FDA said on its website.
“The recommendations in these guidelines build on the FDA’s longstanding commitment to developing and applying innovative approaches to the regulation of AI-enabled devices.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.