I agree with others that the Design History File (DHF) is a living document. The FDA states that ” the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.” To add to the conversation, as @thuytienlecao mentions its important to have the DHF as a living document because if the FDA audits you, you need to have a traceability matrix through the entire process from development to manufacturing. If the safety and efficacy and processes isn’t transparent during the inspection, the FDA could do a 483 observation and require you to fix your DHF. That’s why its important to keep DHF as a living document and update and keep it organized.

https://www.fda.gov/ICECI/Inspections/ucm256377.htm