Topic archive
MedTech Current publications and recall entries tagged Change Management.
FDA's October 20 update highlights hypothetical pathways for hospital-specific sepsis models and automated ECG model retraining. The examples connect planned changes with validation, controlled deployment and continued oversight, without authorizing unrestricted learning.
FDA’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today. The draft explains what planned device modifications may be appropriate for a PCCP and the information FDA expects manufacturers to provide.
HSA’s supplementary change-notification guidance for EU MDR/IVDR transition changes is no longer current and is listed as archived. Registrants should now assess EU-driven labelling, IFU, and other changes under the current GN-21 R7 change-notification framework.