The United States Food and Drug Administration has announced the availability of its final guidance on AI 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 promoting the development of safe and effective AI-enabled devices,” a the agency said in a statement. Tuesday.
WHY IT IS IMPORTANT
The guide provides recommendations on what information to include in a marketing submission for a device with one or more AI-enabled device software features. The FDA said that for changes to the software functions of artificial intelligence-based devices, or AI-DSF, that are expected over time, the agency will not require an entirely new market submission.
“Because the changes specified and implemented in accordance with an authorized PCCP have been reviewed and authorized via the marketing submission containing the PCCP, the changes may be implemented in the AI-DSF without requiring a new marketing submission “, said the FDA in this is final guidance published in the Federal Register.
Instead, the agency said it would focus reviews of the changes “on those aspects of the device that are most significantly changed,” and suggested submitting documents with tracked changes.
The agency will host a webinar on Jan. 14, 2025, to allow industry and others to learn more about the final guidance, according to its announcement.
THE BIGGEST TREND
The agency said that while it is committed to deploying new devices more quickly, it will take a science-based approach to meeting its requirements for AI and ML-powered medical devices.
The agency considered ways to avoid multiple submissions for technologies that may evolve and to streamline the ongoing regulatory review process for developers throughout medical device lifecycles.
The draft guidelines took into account performance regarding race, ethnicity, disease severity, sex, age and geographic considerations in the development, validation, implementation and monitoring AI/ML-enabled devices are underway, according to Brendan O’Leary, deputy director of Digital Health. Center of Excellence for the FDA’s Center for Devices and Radiological Health, in the agency’s March announcement opening a public comment period.
ON THE FILE
“The recommendations in this guidance apply to AI-enabled devices, including components of device-driven combination products, reviewed through the 510(k), De Novo, and PMA pathways,” the FDA said in its website.
“The recommendations in this guidance build on FDA’s long-standing commitment to developing and applying innovative approaches to the regulation of AI-enabled devices. »
Andrea Fox is the editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.