All terms
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
Related terms
Shared paths + categoryQuality & Risk
Design Controls
Structured process governing the design of medical devices.
QMS Foundations
Standards
ISO 13485
International standard for medical device quality management systems.
QMS Foundations
Quality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
QMS Foundations · adjacent
Quality & Risk
Verification & Validation(V&V)
Confirming design outputs meet inputs (V) and that devices meet user needs (V).
QMS Foundations · adjacent
Quality & Risk
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
QMS Foundations
Quality & Risk
FDA Form 483
Notice of inspectional observations issued at the conclusion of an FDA inspection.
QMS Foundations
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1ISO·1
- 121 CFR 820.30(j)VerifiedeCFRecfr.gov
- 2FDA - Quality SystemsVerifiedFDAfda.gov
- 3ISO 13485 Standard PageVerifiedISOiso.org
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