March 13, 2023

DHF Documentation of Design Changes

Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF).  Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF.  Accordingly, if your system does that for each type of device via a single DHF or via a composite of DHFs, then both ways can work.  Accordingly, the main focal point is instead for us to be sure that the DHF, in whatever format we use, ultimately captures those changes via proper design change principles and procedures.  Indeed, it is common and expected that the design attributes, such as the intended use or indications, might evolve, or be refined, during the design process.

For example, the U.S. FDA has said that we are not expected to maintain records of changes made during the very early stages of product development.  Instead, only those design changes made after the approval of the design inputs need be documented using proper design change controls.  So, as long as the evolution of your intended use and indications are properly managed and processed using proper design change controls, then you should be on solid ground.  For example, if the changes made to the intended use or indications are no longer representative of the intended use or indications for which you’ve previously completed design verification and/or validation, then those studies would need to be supplemented or redone.  As long as your DHF, in whatever form you keep it, captures this, then that would be a compliant DHF.