AI in Cutting-Edge Medical Devices: Strategies for Navigating the Streamlined FDA Approval Process

January 18, 2024

Join Mark Gardner, Directing Attorney at Gardner Law and Kyle Faget, Partner at Foley & Lardner, for a CLE webinar that will guide healthcare practitioners through the FDA approval process for AI medical devices including Software as a Medical Device (SaMD) and the attempts by the FDA to streamline the regulatory process. The experts will discuss the FDA's recent draft guidance related to using PCCPs in marketing submissions, including drafting considerations, how PCCPs may streamline the FDA approval process, and best practices for using PCCPs.

Register to attend virtually on January 18, 2024 from 1:00pm-2:30pm EST (10:00am-11:30am PST).


The FDA's regulatory framework governing the approval of medical devices is time-consuming and complex, which is problematic with the advent of AI where technology is rapidly evolving. The challenge arises where certain AI software considered to be a medical device itself (SaMD) must go through the FDA's lengthy approval process, which could include re-submissions for approval under certain circumstances, that may slow the growth and development of lifesaving technology.

Such is the case with machine learning-enabled device software functions (ML-DSFs) that use algorithms to "learn" from numerous examples in a dataset without being explicitly programmed to reach a particular answer or conclusion. The FDA recognizes that the advantage of ML-DSF is the ability to improve performance through iterative modifications, which is in tension with the FDA's traditional framework for premarket review of changes to a medical device.

Therefore, in an effort to keep up with technology, the FDA is establishing a regulatory framework that will allow the agency to maintain the safety and effectiveness of medical devices without unnecessarily slowing progress. Included in this developing framework is the recently released draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" which addresses the use of PCCPs that may allow manufacturers to obtain premarket authorization for pre-specified automatic and manual modifications that may be made to ML-DSFs without re-submitting the device for FDA review.

Listen as our expert panel guides practitioners through the FDA approval process for SaMD and the current status of FDA regulation for approving AI medical devices. The panel will discuss the FDA's draft guidance related to using PCCPs and best practices for compliance.