AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans
Summary
Despite this, the new final PCCP Guidance is still most applicable to ML-enabled devices that would benefit from preapproved modifications based on continued learning. Despite significant pushback from commentors, PCCPs are not permitted for use in special 510(k) applications, which is an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and where design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence. We strongly recommend that manufacturers discuss their PCCP plans with FDA to ensure that there is agreement on the requirements and regulatory pathway. The PCCP Guidance discussed the importance of labeling to ensure that consumers are aware of the potential for post-market modifications of an AI-DSF. FDA anticipates that modifications to PCCPs will require a new marketing submission because of the risk that the modified PCCP may significantly affect the safety or efficacy of the device.