GLOSSARYUS

Design History File Legacy term

A compilation of records the Quality System Regulation required for each device type, showing that the design followed the approved design plan and the regulation. The design and development file now serves this purpose.

Replaced by: Design and development file, ISO 13485:2016 clause 7.3.10
Where the replacement is written: ISO 13485:2016 clause 7.3.10; 89 FR 7496, response to comment 31
Old rule: 21 CFR 820.30(j), in Part 820 before February 2, 2026
Also called: DHF

Avoid This Mistake

A procedure that still cites 21 CFR 820.30(j) points to a section the current Part 820 does not contain.

Related terms

Design and Development File Device Master Record

All Terms Run the Design Controls & V&V Completeness Diagnostic