The FDA-cleared artificial intelligence technologies previously granted marketing authorization have generally been viewed as “locked” algorithms, meaning they do not continue to adapt or learn each time they are used. Today, however, the FDA is moving beyond these basic device types and looking toward true AI ML systems, including machine learning algorithms that evolve over time and are often described as “adaptive” or “continuously learning” algorithms. These adaptive algorithms can learn from new user data gathered through real-world use. The FDA is considering a framework that would allow algorithm modifications through real-world learning and adaptation while continuing to maintain the safety and effectiveness of software as a medical device, or SaMD, without creating the need for frequent updates or repeated submissions. This webinar will review information related to devices that include artificial intelligence algorithms capable of real-world modifications that the Agency would expect to review before market release. This includes algorithm performance, added concerns around AI / ML software V&V, the manufacturer’s modification plan, and the manufacturer’s ability to manage and control modification risks, including the software’s “predetermined change control plan” (PCCP).
As artificial intelligence / machine learning software learns from real-world feedback and improves its performance, it is driving innovation and supporting the creation of new medical devices. The FDA understands both the advantages and risks of AI and has begun outlining its expectations for industry, device design, programming, Model validation, unique documentation concerns, and submissions.
Areas Covered in The Session:-
Background:-
For regulated companies, this webinar will offer valuable support in reviewing current or planned AI medical device R&D and production activities, along with the documentation requirements currently anticipated by the US FDA. This information is relevant to personnel / companies in the Medical Device and some Combination products fields. The employees who will benefit include those involved in Submission strategy, regulatory planning, and related documentation activities.
Why You Should Attend:-
Because the US FDA has outlined the steps required for a regulatory framework, manufacturers developing safe and effective medical devices that use advanced artificial intelligence / machine learning algorithms need to understand how these expectations apply. Artificial intelligence algorithms are software systems that can learn from data and act on that information. These algorithms are already being used to help screen for diseases and support treatment recommendations.
The authorization of these technologies signals the progress the FDA expects as more medical devices begin using advanced artificial intelligence algorithms to improve performance and safety. Since AI changes over time, a key question is how the Agency will control these changes without requiring new marketing submissions. AI software evaluation also brings new requirements. The Agency intends to use its current authorities in new ways to keep pace with innovation while helping ensure device safety.
Who Will Benefit:-
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