What a design history file is
A design history file (DHF) is the collection of records that shows how a medical device was designed: the plan, the inputs, the outputs, the reviews, verification and validation, design transfer and every design change. It is the evidence that design controls were actually followed. For more than 25 years, US device makers kept a DHF because the former Quality System regulation required one for each type of device.
That changed on February 2, 2026. The Quality Management System Regulation (QMSR) took effect, incorporated ISO 13485:2016 by reference, and dropped the DHF as a defined term. The obligation did not go away: the evidence now lives in the design and development file that ISO 13485 clause 7.3.10 requires.
For how software helps keep a DHF inspection-ready, see Design History File Software: How to Build an Inspection-Ready DHF Under QMSR.
What changed under the QMSR
| Topic | Before February 2, 2026 | Since February 2, 2026 |
|---|---|---|
| Design control rule | 21 CFR 820.30 | ISO 13485:2016 clause 7.3, incorporated by reference (FDA, QMSR Design and Development) |
| Design record | Design history file (DHF) | Design and development file (clause 7.3.10) |
| Device specifications | Device master record (DMR) | Medical device file (clause 4.2.3) |
| Scope | Class II, Class III and certain Class I devices | Same: 820.10(c) applies design and development to “All Class II and Class III medical devices” and Class I “Devices automated with computer software” (FDA) |
| FDA guidance | 1997 Design Control Guidance | Withdrawn on 02/02/2026 (FDA, Withdrawn guidance) |
| Inspection method | QSIT | QSIT discontinued; new compliance program (AABB) |
The content barely moved. In the final rule, FDA wrote that “consistent with the former DHF, Clause 7.3.10 requires the design and development file to contain or reference all the records necessary” to show conformity (Federal Register). FDA’s own training slides say organizations “must maintain a design and development file for each medical device type or medical device family” that includes or references “records that demonstrate conformity to the design and development requirements” (FDA).
Many teams still say “DHF” internally. That is fine, as long as procedures, templates and training reference the current clauses and the file meets 7.3.10.
What belongs in the design and development file
The file should let an outsider follow the design from user needs to production. Using the clause structure FDA presents in its QMSR training:
| ISO 13485 clause | Records to keep | What reviewers check |
|---|---|---|
| 7.3.2 Planning | Design and development plan, stages, responsibilities, traceability methods | Plan updated as the project changed |
| 7.3.3 Inputs | Requirements, including regulatory and standards requirements and risk management outputs | Inputs are “complete, unambiguous, able to be verified or validated, and not in conflict with each other” |
| 7.3.4 Outputs | Drawings, specifications, software, labeling, acceptance criteria | Outputs trace to inputs; essential characteristics identified |
| 7.3.5 Review | Design review minutes, attendees, actions | Independent reviewer; actions closed |
| 7.3.6 Verification | Protocols, reports, statistical rationale | Outputs meet inputs; interfaces confirmed |
| 7.3.7 Validation | Clinical or simulated-use evidence, human factors, software validation | Done on representative product, before release |
| 7.3.8 Transfer | Transfer plan, manufacturing readiness | Outputs verified as suitable for manufacturing |
| 7.3.9 Changes | Change records, impact assessment, re-verification | Significance assessed; reviewed, verified or validated, approved |
| 7.1 Risk management | Risk management file links | Risk controls traced to requirements and tests |
Requirement phrases quoted from FDA, QMSR Design and Development.
Why DHF quality still drives enforcement
Design records remain a frequent source of warning letters. Covington counted design control violations (21 CFR 820.30) “in seven letters” in its review of device warning letters from January to March 2026 (Covington); those inspections predated the QMSR and cite the old section numbers.
A January 2026 warning letter to a continuous glucose monitor maker shows what inspectors read in a design file. FDA found that the firm’s “design transfer process did not ensure that performance specifications” were met, that its design transfer plan “does not describe how” accuracy specifications flowed to external sites, and concluded the firm “has not adequately validated its manufacturing and release controls” (FDA warning letter, Abbott Diabetes Care). Each gap was visible in design records.
How to run a DHF review or DHF audit
- Map the file to clause 7.3. Build an index of every required record and where it lives.
- Trace a sample of requirements end to end: user need, input, output, verification, validation, risk control.
- Check design reviews for independent participants, decisions and closed actions.
- Read verification and validation reports critically: sample sizes, acceptance criteria, deviations and representative product.
- Follow design changes after launch and confirm impact assessments and re-verification.
- Confirm design transfer shows manufacturing can meet specifications, including at suppliers.
- Check the vocabulary: procedures and templates should reference the QMSR and ISO 13485, not the removed 820.30.
- Record findings with evidence and route gaps to CAPA.
DHF checklist
- One design and development file per device type or family, with an index
- Current design and development plan with stages, responsibilities and traceability methods
- Inputs include regulatory, standards and risk management requirements
- Outputs trace to inputs and contain acceptance criteria
- Design reviews recorded with independent reviewer and closed actions
- Verification protocols and reports with statistical rationale
- Validation on representative product, completed before release
- Design transfer evidence, including external manufacturing sites
- Design changes assessed, verified or validated, and approved
- Risk management file linked to requirements and tests
- Procedures updated for the QMSR; 1997 guidance and 820.30 references retired
Check your design file against the clauses, with evidence
A design file can hold thousands of pages, and gaps hide in the links between them. AskDona reviews design and development files against ISO 13485 clause 7.3, the QMSR or your own procedure, flags missing records, broken traceability and weak verification evidence, and cites the passage behind every finding.
Run a sample DHF assessment on one device’s design file. AskDona shows the evidence; your engineering and quality teams decide.
FAQ
What does DHF stand for? Design history file: the records showing how a medical device was designed and developed.
Is the DHF still required under the QMSR? The term is gone, but ISO 13485 clause 7.3.10 requires a design and development file that, in FDA’s words, is “consistent with the former DHF” (Federal Register).
What is the difference between the DHF and the medical device file? The design file records how the device was designed; the medical device file (clause 4.2.3) holds current specifications and procedures, similar to the former DMR.
Is FDA’s 1997 design control guidance still valid? No. FDA lists it as withdrawn on February 2, 2026 (FDA).
Which devices need a design and development file? Class II and Class III devices and Class I devices automated with computer software, per 820.10(c) (FDA).
References
All pages opened and checked by October 14, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: QMSR Design and Development (slides) | Regulator training | 2026 | Clause 7.3 content, 820.10(c) scope |
| Federal Register: QMSR final rule | Regulator | Feb 2, 2024 | DHF to design and development file |
| FDA: Withdrawn guidance | Regulator | Current | 1997 guidance withdrawal |
| AABB: FDA implements QMSR | Professional body | Feb 4, 2026 | QSIT discontinued |
| Covington: Device warning letters Q1 2026 | Law firm | May 15, 2026 | Design control letters |
| FDA warning letter: Abbott Diabetes Care | Regulator | Jan 23, 2026 | Design transfer and validation |