The artificial intelligence technologies granted FDA marketing authorization and cleared by the Agency have mostly been "locked" algorithms that don’t continually adapt or learn every time the algorithm is used.
Now the FDA is looking beyond these elemental devices to those capable of true AI, - machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms. Adaptive algorithms can learn from new user data presented to the algorithm through real-world use. The FDA is now regulating modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device (SaMD), without requiring frequent updates or submissions.
This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the Agency would require for premarket review. They include the algorithm’s performance, the added concerns for AI / ML software Verification and Validation, the manufacturer’s plan for modifications, and the ability of the manufacturer to manage and control risks of the modifications, including the software’s "predetermined change control plan" (PCCP).
The US FDA has announced a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence/machine learning algorithms/software/firmware. Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations.
The FDA recognizes that medical devices will incorporate advanced artificial intelligence algorithms to improve their performance and safety. Since AI changes over time, how will the Agency control these changes without requiring new marketing submissions? AI software validation has some new requirements as well. The FDA is continually developing new ways to keep up with the rapid pace of innovation and ensure the safety of such AI-enabled devices, requiring adjustments in the way companies meet these requirements in their V&V, documentation, and post-market monitoring.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated AI medical device R&D and production activities and documentation requirements, as currently required by the US FDA. This information applies to personnel/companies in the Medical Device and some Combination products fields. The employees who will benefit include:
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products that are software-driven, and the resultant documentation and submission requirements.
John E. Lincoln is an experienced professional in the industry, specializing in Webinar sessions. With deep expertise in the subject matter, they bring practical insights and real-world knowledge to every presentation.
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