We are starting our gap analysis for the 2026 QMSR transition. Since we have SaMD products, we are seeing a lot of overlap between the new FDA requirements and the upcoming EU AI Act documentation. To avoid maintaining duplicate files, I put together a matrix mapping the new 21 CFR 820 clauses directly against ISO 13485 and the EU "High-Risk AI" requirements. It covers the PCCP "Region of Modification" definitions and the EU FRIA sections.
I've uploaded the draft PDF here if anyone wants to use it as a reference:
I tried to attach the direct link, but since I'm a new member, the forum won't allow me to post active URLs yet. You can find the PDF by going to:www . synapticdigest . com / toolkit (Just remove the spaces)"
One question for the group: regarding the PCCP section, are you interpreting the "Modification Protocol" as a strictly locked verification method? I'm trying to figure out if there is any flexibility for a "range of specs" approach for retraining, or if the FDA is requiring fixed parameters only.
Thanks.
I've uploaded the draft PDF here if anyone wants to use it as a reference:
I tried to attach the direct link, but since I'm a new member, the forum won't allow me to post active URLs yet. You can find the PDF by going to:www . synapticdigest . com / toolkit (Just remove the spaces)"
One question for the group: regarding the PCCP section, are you interpreting the "Modification Protocol" as a strictly locked verification method? I'm trying to figure out if there is any flexibility for a "range of specs" approach for retraining, or if the FDA is requiring fixed parameters only.
Thanks.
