The FDA's Action Plan Regarding Artificial Intelligence and Machine Learning - Channelchek

Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices. A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”. The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”