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CATEGORY: DOCUMENTATION
Design History File (DHF)
A compilation of records describing the design history of a finished medical device. The DHF contains or references all design control documentation required by FDA 21 CFR 820.30.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
The Design History File (DHF) applies to manufacturers who design medical devices under FDA quality system requirements (and analogous design-control frameworks). It is the compilation of records that demonstrate design was developed according to the approved design plan.
PROCESS / STEPS
- Maintain DHF as a living index of design inputs, outputs, reviews, verification, validation, and transfer records.
- Link each design change to risk management and, when required, regulatory submissions.
- Ensure DHF is inspection-ready: traceability from user needs → design inputs → outputs → V&V → DMR.
- Archive superseded revisions with controlled document numbers.
EXAMPLES
- An infusion pump DHF includes software requirements, cybersecurity threat models, biocompatibility reports, and design transfer checklists.
COMMON MISTAKES
- Treating DHF as a binder assembled only before audit rather than continuous design control evidence.
- Missing links between design changes and updated risk files or labeling.
RELATED GUIDES & TOOLS
SOURCES
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