Maps to
QMSR / ISO 13485: §820.30(j)
ISO 13485: §7.3
Requirement text
A Design History File (DHF) must be established and maintained for each type of device. The DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and applicable regulatory requirements.
What changed
Part 820.30(j) explicitly required each manufacturer to establish and maintain a Design History File (DHF) for each type of device. The DHF had to contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of Part 820.
The QMSR transition introduces a terminology and structural shift. ISO 13485:2016 clause 7.3.10 requires a 'design and development file' (DDF) for each medical device type or medical device family. The DDF must contain or reference records generated during design and development to demonstrate conformity to the requirements for design and development and records of design and development changes. While the term changes from DHF to DDF, the regulatory intent is fundamentally the same: a complete, retrievable compilation of all design control records for a device.
However, the QMSR adds nuance that companies should not overlook. The FDA's QMSR retains certain 'FDA-plus' requirements beyond base ISO 13485. Specifically, QMSR section 820.30 requires that the DHF/DDF demonstrate compliance with the approved design plan — a more specific requirement than ISO 13485's general conformity language. The FDA expects the file to tell the story of the design: from initial planning through inputs, outputs, reviews, verification, validation, transfer, and changes, with a clear narrative showing that each activity was performed as planned.
The scope of what must be in the file has also expanded implicitly. Because ISO 13485 integrates risk management into design controls (7.3.3), the DHF/DDF must now include or reference the risk management file and traceability between risk management outputs and design activities. Under Part 820, the risk management documentation was often maintained separately from the DHF. Under QMSR, auditors expect to see risk management records as part of the design history.
Additionally, the QMSR's incorporation of ISO 13485 means the DHF/DDF must address all the expanded requirements across the design control sub-clauses — including interface management documentation, prior design references, usability evaluation records, clinical evaluation data, manufacturing suitability verification, and delivered product impact assessments for design changes. A DHF that met Part 820 requirements may be structurally incomplete under the expanded QMSR framework.
Atomic constraints
- •A Design History File must be established and maintained for each device type.
- •The DHF must contain or reference all design control records (planning, inputs, outputs, reviews, verification, validation, transfer, changes).
- •The DHF must demonstrate design was developed per the approved design plan.
- •The DHF must be retrievable and available for FDA inspection.
- •Design change records must be incorporated into the DHF.
- •The DHF must include or reference the risk management file and risk management records as design inputs per QMSR 820.30(c)/ISO 13485 7.3.3.
- •The DHF must include evidence that all required design control stages were conducted at the stages specified in the design and development plan.
- •The DHF must include records of design reviews with attendee lists, findings, and action items.
- •The DHF must be maintained as a living compilation throughout development, not assembled retrospectively after design transfer.
- •A DHF completeness verification must be documented at or before the time of design transfer, confirming all required records are present and approved.
Common gaps
DHF missing risk management file integration
majorUnder QMSR, the design history must include or reference risk management records because ISO 13485 7.3.3 makes risk management outputs a design input. Many Part 820-era DHFs do not reference the risk management file, hazard analyses, or risk control traceability as part of the design history.
No DHF completeness review at design transfer
moderateISO 13485 7.3.10 and good practice under the QMSR require that the DHF/DDF be verified for completeness — confirming all required records are present, approved, and retrievable — before or at the time of design transfer. Many companies compile the DHF retrospectively rather than verifying its completeness as a design transfer gate.
DHF does not include records for expanded QMSR requirements
moderateThe QMSR's incorporation of ISO 13485 expands the scope of design control records beyond what Part 820 required. DHFs that met Part 820 may lack records for interface management, prior design references, usability evaluation, clinical evaluation, and manufacturing suitability verification — all now expected as part of the design history.
Fragmented design records
moderateRecords of design changes or verification results are stored in personal drives or physical binders not referenced in a central 'DHF index.' ISO 13485 §7.3.10 requires the file to be maintained for each design.
Missing legacy DHF for ISO-only systems
moderateISO-certified firms moving to the U.S. market often lack the 'DHF' structure, having only a 'DDF' that may miss earlier design iterations.
Evidence signals
- •
FILE_EXISTS
(Design.*History.*File|DHF|Design.*History|DHF.*Index)
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CONTENT_MATCH
Does this document serve as or reference a design history file, listing design control records including planning, inputs, outputs, reviews, verification, validation, and transfer for a specific device?
Audit defense
The Design History File for [your product] is maintained as [your document ID]. The DHF index references all design control records — from the Design and Development Plan through design transfer — demonstrating that [your product] was developed in accordance with the approved design plan and QMSR 820.30 requirements. The DHF is available for FDA inspection.