Effective Feb. 2, 2026, FDA's Quality Management System Regulation (QMSR) incorporated ISO 13485:2016 by reference, and that retired three terms medical device teams have used for decades: the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR). In their place are the Design and Development File (DDF) and the Medical Device File (MDF). Most of your content maps over one to one. Some of it does not.

This map tells you which elements are a straight rename and which involve a real change in what you document or where it lives, clause by clause, so you do not treat a substantive shift as a find-and-replace. It includes a records inventory worksheet to audit your own system against the new structure, and an appendix on rebuilding a DDF and MDF from an existing 510(k) if you are remediating after the fact.