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    Quality & RiskQuality SystemDHF

    Design History File

    Compilation of records describing the design history of a finished device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 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.
    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

    Contains

    Sub-elements or required artefacts of this term.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.30(j)
      Verified
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.