The United States’ Food and Drug Administration (FDA) has recently released a draft guidance title “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” This document follows the passage of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which allows the FDA to approve or clear Predetermined Change Control Plans (PCCPs) for devices that require premarket approval (PMA) or premarket notification (510(k)).
This draft guidance focuses specifically on machine learning-enabled device software functions (ML-DSFs) that manufacturers may plan to modify over time. This document requires manufacturers to submit a PCCP with a marketing submission (i.e., a 510(k), PMA, or de novo request). In order to establish a PCCP, the submission should include all relevant marketing submission requirements, along with a description of the modifications and a “Modification Protocol.” The document should also include an “Impact Assessment,” which entails documentation of the assessment of the benefits and risks of implementing a PCCP for an ML-DSF and any mitigation of these risks.
FDA encourages manufacturers to reach out for feedback from their representatives early on in the process in order to ensure that all of the necessary documents, information, and requirements are included. This submission process will help to ensure that the device remains safe and effective as it undergoes modifications.
Mondaq Ltd helps millions of individuals and businesses gain access to global business and regulatory news. 1.8 million like-minded professionals seek out and share the answers they need on their website. They provide a subscription-based online library of global content and analysis, helping customers proactively access relevant legal and regulatory updates specific to their industries. The company also offers a suite of tools, including software and services, to help customers stay up-to-date. With over 6 Million readers in more than 120 countries, Mondaq has earned a reputation for being the global leader in news and knowledge.
