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Design History File
Compilation of records describing the design history of a finished device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
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. What the regulation says
The FDA, under 21 CFR 820.30(j), mandates that each manufacturer shall establish and maintain a Design History File (DHF) for each type of MedTech. The DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements. Similarly, ISO 13485:2016, in clause 7.3.10, requires that the organization shall maintain records of the results of design and development. The International Medical Device Regulators Forum (IMDRF) also emphasizes the importance of design and development documentation in their guidance on regulatory convergence.What this means in practice
The DHF is a key inspection artifact. Under the upcoming QMSR, the DHF concept is harmonized with ISO 13485's design and development records.Examples
- A DHF might include meeting minutes from design reviews, showing discussions and decisions made during the design process for a new surgical robot.
- For a software as a MedTech (SaMD), the DHF would contain software requirements specifications, architecture diagrams, and records of software testing and verification results.
- A manufacturer of an implantable MedTech will have in their DHF records of biocompatibility testing, material specifications, and sterilization validation reports.
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.
Frequently asked questions
The primary purpose of a DHF is to provide objective evidence that the MedTech was designed and developed according to the established design control procedures and regulatory requirements, such as FDA 21 CFR 820.30.
Cross-references
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
Link health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1ISO·1
- 121 CFR 820.30(j)Tier 1 VerifiedeCFRecfr.gov
- 2FDA - Quality SystemsTier 2 VerifiedFDAfda.gov
- 3ISO 13485 Standard PageTier 1 VerifiedISOiso.org
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