FDA Finalizes Guidance on AI-Enabled Device Updates with PCCPs

The FDA has recently finalized guidance on post-market regulation of artificial intelligence (AI)-enabled medical devices, focusing on pre-determined change control plans (PCCPs). These PCCPs enable manufacturers to implement iterative enhancements to device algorithms without the need for additional submissions to the FDA, addressing the limitation of "locked" AI algorithms which lack adaptivity over time[1][2]. Initially introduced in 2019, this regulatory framework now includes a section on version control and maintenance, ensuring the safety and effectiveness of devices align with their intended use[2]. While significant modifications outside the PCCP's scope still require new marketing submissions, the FDA emphasizes the importance of precise device labeling to alert users of potential software modifications specific to these PCCPs[1].