Total Product Lifecycle
USA: FDA – The highly iterative, autonomous, and adaptive nature of adaptive AI/ML technologies requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards (Source: “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”).
This proposed TPLC approach allows FDA’s regulatory oversight to embrace the iterative improvement power of AI/ML SaMD while assuring that patient safety is maintained. It also assures that ongoing algorithm changes are implemented according to pre-specified performance objectives, follow defined algorithm change protocols, utilize a validation process that is committed to improving the performance, safety, and effectiveness of AI/ML software, and include real-world monitoring of performance. Thisproposed TPLC regulatory framework aims to promote a mechanism for manufacturers to be continually vigilant in maintaining the safety and effectiveness of their SaMD, that ultimately, supports both FDA and manufacturers in providing increased benefits to patients and providers (Source: “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”).
