FDA documents for medical devices: DHF, DMR, and DHR explained

If you’re building a regulated product, the FDA requires controlled documentation and records that prove you designed the device under design controls, defined how it should be manufactured, and can demonstrate what you actually produced.

Historically, teams organised this evidence into three buckets: DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record) as a practical way to keep design and manufacturing traceability audit-ready.

As of February 2, 2026, the FDA’s QMSR is in effect and incorporates ISO 13485:2016 by reference, while keeping additional U.S.-specific requirements in 21 CFR Part 820 and related regulations. That changes the regulatory terminology you’ll see, but the underlying expectation—objective evidence, controlled records, and traceability—still drives inspections. 

FDA documents for medical devices: where DHF, DMR, and DHR fit

A simple way to understand DHF/DMR/DHR is as a lifecycle chain:

• DHF is proof you designed the device the right way (design controls evidence)
• DMR (or “Medical Device File” under ISO 13485:2016) is the “how to build it” master set (manufacturing instructions/specs)
• DHR is proof that you built it according to the master set (production/acceptance records)
  

This “instruction manual” framing is useful in practice: the DMR is the instruction manual; the DHF shows how that manual was developed; and the DHR proves you followed it.

Practical checklists: what each file typically includes 

The contents of your specific FDA documents for your own medical devices depend on device risk, complexity, and your procedures, but the goal is always the same: clear objective evidence and traceability.

Use the checklists below as implementation guidelines.

DHF checklist (Design History File / Design & Development File)

As the name suggests, the DHF focuses on the design history, ensuring it was carried out in accordance with FDA regulations. The legacy requirement found in 21 CFR Part 820.30 stipulates:

“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of this part.” 

This requirement is met under ISO 13485:2016 Clause 7.3 (incorporated by reference), which states that ‘a design and development file’ must be created for each medical device type.

Importantly, ISO notes that the DHF should record all changes made to the design during the planning and development process.

“The organization shall maintain a design and development file for each medical device type or medical device family. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.”

To this end, the DHF should contain:

• Approved design and development plan (phases, responsibilities, deliverables)
• User needs / intended use and measurable design inputs
• Design outputs (drawings, specs, software requirements, labelling drafts)
• Design reviews (agenda, attendees, decisions, actions)
• Verification plans/results and validation plans/results (including usability where applicable)
• Risk management links (hazards, controls, residual risk acceptance) and risk/design traceability
• Design transfer evidence (how you ensured manufacturing can reliably build it)
• Design changes, deviations, and rationale (with approvals)
• Traceability matrix (requirements ↔ risks ↔ tests ↔ releases)

DMR checklist (Device Master Record / “how to build it” master set) 

If the DHF shows how the device design and its production specifications were developed and approved, then the DMR is the released 'how to build it' baseline, and the DHR is the proof that individual units or lots were built and accepted against it.

In other words, it contains all the information needed to produce the device safely, in accordance with the design and the regulations that cover it.

Section 820.181 of the legacy FDA QSR was quite specific about what the device master record should contain. Still, under ISO 13485:2016, the specific details required remain:

• Device specifications (configuration, drawings, BOM, materials)
• Manufacturing/assembly instructions and process specifications
• Test/inspection procedures, acceptance criteria, and sampling plans
• Packaging and labelling specifications (including UDI placement rules where applicable)
• Required tooling/equipment specs and maintenance/calibration references
• Released software/firmware build identifiers and release notes (if applicable)
• Approved suppliers, incoming acceptance criteria, and critical component specs
• Servicing/installation instructions where applicable

DHR checklist (Device History Record/production records)

The DHR is the final proof that you have used the ‘instruction manual’ (DMR) and followed its instructions to correctly manufacture the device.

Under 21 CFR 820.184, the FDA states, “Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e) The primary identification label and labelling used for each production unit; and

(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.”

Common pitfalls and tips for digital organisation and traceability

The FDA expects controlled, current approved versions, full change history, and rapid retrieval with clear traceability.

To meet these standards, use a single controlled source of truth, like an eDMS (electronic document management system), where one approved record can be referenced across DHF, DMR, and DHR views without creating uncontrolled duplicate copies.

Choose an eDMS that lets you:

• Define the contents of these critical files at the start of your project,
• Automatically populate them with approved content as your project progresses
• Update them, subject to required version and change controls
• Make a full audit history of every document available in each file
• Make the latest approved version of each file (DHF, DMR or DHR) available to auditors - on demand

Conclusion

Each of the three Ds of medical device development has a different function within the FDA's regulatory scheme. They are outputs that, taken together, prove complete compliance in each phase of the development and manufacturing process

Using the right DMS will allow you to digitise the production and audit of these three critical review items. It will save you time, money and stress as you design, manufacture, and manage your device in the future.

Download our free guide to Medical Device Development, or see how a structured DMS/eQMS like Cognidox can help you organise FDA medical device documents with controlled workflows, audit trails, and fast retrieval. 

FAQs

1. What are the main FDA documents for medical devices?

Most teams focus on the documentation that proves design and manufacturing control, being 1) design and development records (often managed as a DHF), 2) manufacturing specifications (often managed as a DMR/MDF), and 3) production records (often managed as a DHR). Under QMSR, the FDA aligns Part 820 to ISO 13485 while still expecting objective evidence and traceability.

2. DHF vs DMR vs DHR: what’s the difference?

 DHF explains how the device design was developed and verified/validated; DMR defines how the device must be built and tested; and DHR proves what was actually built and that it met the acceptance criteria. They connect as a lifecycle chain: design controls → manufacturing definition → production proof. 

3. Does QMSR eliminate DHF, DMR, and DHR?

QMSR shifts the regulatory framework to ISO 13485:2016 incorporated by reference, and Part 820 no longer centres the legacy DHF/DMR/DHR terminology in the same way. Practically, the concepts remain—you still need organised design records, device files/manufacturing specs, and production records that inspectors can trace.

4. How do DHF/DMR/DHR map to ISO 13485?

A common mapping is: DHF → design and development records (ISO 13485 Clause 7.3), DMR → medical device file plus production specifications, and DHR → production/acceptance records maintained under ISO 13485 record controls. Under QMSR Part 820, compliance is explicitly tied to ISO 13485 clauses.

5. What’s the fastest way to make these audit-ready?

Define your file structure early, control revisions, and ensure every requirement can be traced to verification and to production acceptance evidence. Then practice retrieval: pick a requirement and a lot number, and confirm you can quickly pull the full evidence chain.

Last updated on 17/03/2026