DHF
Design History File · design history file · dhf · dhf medical device · 21 cfr 820.30 design controls
A Design History File is the compilation of records that demonstrates a finished device was developed in accordance with its approved design plan and 21 CFR 820.30 design controls.
The Design History File (DHF) is the record of how a device was designed. Under 21 CFR 820.30(j) it must contain, or reference, the records necessary to show the design was developed per the approved design plan: design and development planning, design inputs, design outputs, design reviews, verification, validation, design transfer, design changes, and the design history of each change. ISO 13485 clause 7.3 imposes an equivalent requirement through the design and development file.
The three device records are routinely confused. The DHF is how the device was designed. The DMR (Device Master Record, 820.181) is the recipe — the specifications, processes, labelling and QA procedures for building it. The DHR (Device History Record, 820.184) is the proof that one specific unit or lot was built to the DMR. In shorthand: DHF is design, DMR is the recipe, DHR is the evidence. Under the QMSR transition, FDA moves to ISO 13485 vocabulary — 'medical device file' and 'design and development file' — but the underlying evidence expectations do not relax.
DHF findings in FDA inspections cluster on the same failures: design inputs never traced to outputs, verification and validation records that do not close the traceability matrix, and design changes made without a documented review. V5 Ultimate holds the traceability matrix live, ties design changes to controlled change control with e-signature, and links design transfer straight into the DMR and eDHR — so the DHF is assembled as work happens, not before an audit.
- 21 CFR 820.30
- 21 CFR 820.181
- 21 CFR 820.184
- ISO 13485:2016 cl. 7.3
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