The U.S. Food and Drug Administration announced that final guidance on AI medical devices is now available.
The document – Marketing Submission Recommendations for Predefined Change Control Plans for Software Features of Artificial Intelligence-Enabled Devices – aims to provide “a forward-thinking approach to accelerate the development of safe and effective AI-enabled devices.” authorities said in a statement. Tuesday.
Why is it important?
This guidance provides recommendations regarding the information that should be included in marketing submissions for devices with one or more AI-enabled device software features. The FDA said that no entirely new market filings will be required for artificial intelligence-enabled device software function (AI-DSF) modifications that are expected over time.
“Changes specified and implemented pursuant to an approved PCCP are reviewed and approved through a marketing submission that includes a PCCP, allowing changes to be implemented in the AI-DSF without triggering the need for a new marketing submission.” says the FDA. Final guidance will be published in the Federal Register.
Instead, the agency said it would focus its review of changes on “the aspects of the device that have changed most significantly” and proposed submitting documentation tracking the changes.
The agency will host a webinar on January 14, 2025, for industry and other stakeholders to learn more about the final guidance, according to the announcement.
bigger trends
The agency said it will take a science-based approach to requirements for medical devices that leverage AI and ML while working to rapidly deploy new devices.
The agency considered ways to avoid multiple filings for evolving technologies and streamline the ongoing regulatory review process for developers throughout the medical device lifecycle.
Brendan O’Leary, deputy director general of the Digital Bureau, said the draft guidance calls for consideration of race, ethnicity, disease severity, gender, age, and geography in the ongoing development, validation, implementation, and monitoring of AI/ML-enabled devices. It is said that performance in relation to matters is taken into consideration. FDA’s Center for Device and Radiological Health Health Center of Excellence. The agency’s March announcement began a public comment period.
On record
“The recommendations in this guidance apply to AI-enabled devices, including device components of device-driven combination products, that have been reviewed through the 510(k), De Novo, and PMA pathways,” the FDA said on 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 a senior editor at Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a publication of HIMSS Media.
