Quality & Risk
Design History File(DHF)
In one line
Compilation of records describing the design history of a finished device.
Definition
The Design History File (DHF) contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 CFR 820.30.
Typical DHF content includes the design plan, design inputs and outputs, design review records, verification and validation reports, risk management records, design transfer evidence and design changes. Under the QMSR, FDA no longer uses the DHF term by name; ISO 13485 clause 7.3.10 requires 'design and development files', which serve the same purpose. Many companies keep the DHF label for continuity.
Why it matters
The DHF is a key inspection artifact. Under the upcoming QMSR, the DHF concept is harmonized with ISO 13485's design and development records.
Common pitfalls
- •Failing to update the DHF throughout the entire product lifecycle, not just during initial development, is a common oversight.
- •Including only final versions of documents and omitting interim decisions or rationale can lead to an incomplete DHF.
- •Maintaining physical and electronic records in disconnected systems can make DHF retrieval and review challenging during audits.
- •Not cross-referencing DHF contents effectively, making it difficult to demonstrate traceability between design inputs, outputs, verification, and validation.
- •Treating the DHF as a mere paper exercise rather than a dynamic compilation of design evidence often results in critical information gaps.
Sources
- 21 CFR 820.30(j) · eCFR
- FDA - Quality Systems · FDA
- ISO 13485 Standard Page · ISO