FDA QMSR and the End of DMR, DHR and DHF

The FDA’s new Quality Management System Regulation (QMSR) ushers in the most significant overhaul of U.S. medical device quality system requirements in three decades.

Effective February 2, 2026, QMSR replaces the long-standing Quality System Regulation (QSR) under 21 CFR Part 820, harmonizing FDA requirements with ISO 13485:2016, the global standard for medical device quality management.

As part of this transition, familiar terms for records, including Device Master Record (DMR), Device History Record (DHR) and Design History File (DHF), are being replaced with new documentation frameworks -- the Medical Device File (MDF) and the Design and Development File (DDF).

Here we explore the differences and similarities of the new MDF and DDF to these legacy document requirements and offer tips for transitioning to the new format.

Contents

Why is the FDA replacing QSR with QMSR?

From DMR, DHR and DHF, to MDF and DDF

The role of risk and traceability

FDA-specific requirements retained

How build medical device files under QMSR

What your MDF should contain

What to include in your Design and Development file

Best practices for meeting FDA QMSR expectations

What this means for FDA inspections

Final thoughts

Why is the FDA replacing QSR with QMSR?

For decades, the U.S. medical device industry has operated under the Quality System Regulation (21 CFR 820), a prescriptive GMP framework developed in the 1990s. While effective, the QSR diverged from international standards, forcing manufacturers selling globally to manage parallel compliance systems.

The FDA’s new Quality Management System Regulation modernizes 21 CFR 820 by incorporating ISO 13485:2016 by reference, while retaining select FDA-specific requirements. The result is a more globally aligned framework that reduces regulatory duplication and shifts compliance expectations toward risk-based decision-making and process effectiveness, and requires precise documentation across the product lifecycle.

From DMR, DHR and DHF, to MDF and DDF

A cornerstone of the QMSR transition is the restructuring of device records, specifically the sunset of long-standing QSR terminology and its replacement with ISO-aligned concepts. The FDA has rolled these concepts into the Medical Device File and the Design and Development File.

A Medical Device File encompasses all essential information demonstrating conformity for a specific medical device type or family, mirroring what has previously been outlined in the DMR and DHR.

The Design and Development File effectively serves the same purpose as the former DHF, defining inputs and outputs, outlining risk management, verification/validation, transfer procedures and change controls.

Not only does this approach align with ISO constructs, it also supports many additional global medical device regulatory guidelines, allowing a single MDF or DDF to meet the needs of multiple regulatory bodies.

Though terminology is changing, the FDA has emphasized that the underlying record-keeping expectations of the QSR remain largely the same.

The role of risk and traceability

Like ISO 13485, the new QMSR puts greater emphasis on quality management throughout product lifecycle. In this vein, documentation must more clearly reflect full lifecycle traceability, from design through production to post-market control.

In addition, risk is a central concept that should be integrated into all aspects of an organization’s Quality Management System (QMS). Evidence of risk considerations must be seen throughout the product lifecycle as well.

While these are not new concepts for medical device manufacturers, there will now be a broader expectation that risk and lifecycle data be more consistently documented and traceable across the MDF/DDF framework.

FDA-specific requirements retained

Importantly, the QMSR incorporates ISO 13485:2016 but still maintains FDA-specific statutory obligations. This means that some documentation is required by U.S. law even if not explicitly found in ISO.

For example, labeling records tied to Unique Device Identification (UDI) continue to be expected in documentation, consistent with U.S. regulations and as was required under the QSR. These FDA-specific requirements do not appear for the first time under QMSR but are retained and must be integrated into the MDF structure.

How to build medical device files under QMSR

If you’re experienced with DHR, DMR and DHF, the good news is that you likely already have all the information you need to create your MDF. They key is to ensure you can produce complete, controlled records that demonstrate conformity.

Your team may want to continue using DMR, DHF and DHR internally due to familiarity and established workflows. While this is acceptable, it is recommended that official QMS procedures, templates and file structures reflect the new terminology.

To reduce confusion, particularly during FDA or third-party audits, updating QMS documentation terminology, while noting legacy equivalents where appropriate, can improve clarity and inspection readiness.

What your MDF should contain

The MDF concept under ISO 13485 consolidates the controlled information needed to demonstrate compliance for a medical device. The FDA QMSR framework expects that information to be accessible and coherent upon inspection.

As you build your MDF, consider creating a master table of contents with links or references to controlled documents and records in your document control system. Ensure the MDF includes or clearly points to:

• Device definition and intended use

• Device description, variants/configurations, intended use/indications, key performance characteristics

• Device family rationale (if one MDF covers multiple SKUs)

• Specifications and design outputs you actually manufacture to

• Drawings, BOMs, material specs, software/firmware configuration identifiers (as applicable)

• Acceptance criteria and test methods (incoming/in-process/final)

• Manufacturing and quality controls

• Manufacturing instructions / routers / work instructions

• Process controls and monitoring plans

• Process validation package references (where required) and rationale for verification vs validation

• Packaging, labeling, and (if applicable) UDI references

• Label specs, IFU references, packaging specs, and control of artwork changes

• Links to label reconciliation/line clearance and label verification steps

• Installation, servicing, and complaint feedback loop (if applicable)

• Installation requirements, servicing procedures, service records linkage

MDF best practices

• Treat the MDF as a controlled, inspection-ready index that either contains or clearly references the required device documentation.

• Organize the MDF so an investigator can follow a straight line from device definition → to specs → to production controls → acceptance → labeling/UDI → servicing (if applicable).

• Make the MDF traceable to design and development outputs, risk controls, process validation/verification evidence and post-market feedback loops.

What to include in your Design and Development file

The Design and Development File should provide objective evidence that design controls were planned, executed, reviewed and controlled throughout the device lifecycle. Under QMSR, the FDA will expect this evidence to be complete, current and traceable.

• Design and development planning
• Design inputs
• Design outputs
• Design reviews
• Verification
• Validation
• Risk management integration
• Design changes
• Transfer plan and review
• Configuration and document control
• Linkage to post-market activities

DDF best practices

• Maintain a DDF index or table of contents that points investigators to where each element lives. This is especially important if records are distributed across systems.

• If your organization still uses QSR terminology internally, include a brief note such as:

  “This Design and Development File fulfills the design control documentation requirements of ISO 13485:2016 Clause 7.3 and FDA QMSR.”

Best practices for meeting FDA QMSR expectations

Because QMSR is ISO-based by incorporation, the inspection dynamic is expected to shift toward evidence of device controls. The FDA emphasizes additions to the final rule that clarify expectations and concepts in order to prevent inconsistencies.

To make your MDF audit-ready, include an MDF index page with:

• Device/family name(s) and identifiers

• Applicable sites (if multi-site manufacturing)

• Document list + revision levels + effective dates

• Owner and approval history (e-signature trail if electronic)

Provide internal links to:

• Design and development documentation (where the design outputs originate)

• Production and traceability evidence (where you prove you built it correctly)

• Change control (how updates are evaluated/approved and communicated)

Standardize naming and metadata

• Use consistent naming conventions so “specifications” don’t live under five different folders depending on who authored them.

• Apply the same taxonomy across sites to reduce retrieval friction during inspections.

Prove control, not just existence

• Ensure every item in the MDF has undergone proper document control (approved, current revision, accessible history).

• Demonstrate data integrity with time-stamps, audit trail and author/approver and make sure data is easily retrievable.

• Treat the MDF as a controlled, inspection-ready index that either contains or clearly references the required device documentation.

• Make the MDF traceable to design/development outputs, risk controls, process validation/verification evidence and post market feedback loops.

What this means for FDA inspections

One of the most impactful facets of QMSR is how inspections will unfold once the rule takes effect in 2026. Whereas QSR inspections often centered on checking whether specific records existed and conformed to procedures, QMSR inspections should emphasize risk-based evidence, integrated processes and traceable decision-making.

Key changes in inspection expectations include:

• Risk Integration: FDA inspectors will look for evidence of risk evaluation throughout design, production, supplier controls, training and post-market activities. Traceability from risk assessment to corrective actions will be scrutinized.

• Document Accessibility: With the elimination of certain record exemptions that existed under QSR, internal quality records like audit reports, supplier assessments and management reviews can now be requested and reviewed by inspectors. This adds a new level of transparency and accountability to quality systems.

• Process Evidence Over Checkboxes: Inspectors are expected to concentrate on how processes actually work rather than merely verifying SOPs exist. Their focus will extend to whether procedures are executed effectively and produce demonstrable outcomes.

Manufacturers who rely on traditional, paper-centric systems or loosely organized digital files may find these new expectations challenging.

Digital QMS platforms that facilitate rapid document retrieval, audit trails and linkage of records across processes significantly improve readiness for QMSR inspections.

Final thoughts

The QMSR represents a meaningful shift in how medical device quality data is organized, evaluated and presented, but not a wholesale reinvention of what data manufacturers must maintain. In most cases, the information required under QMSR already exists within established DMR, DHR and DHF structures.

What has changed is expectations for how that information is connected, controlled and traceable across the full product lifecycle.

By aligning 21 CFR Part 820 with ISO 13485:2016, QMSR places greater emphasis on risk-based decision-making and end-to-end traceability, from design and development through production and post-market activities.

Documentation must now tell a more complete, coherent story, demonstrating not only that requirements are met, but that risks are understood, mitigated and continuously monitored as the device evolves.

Manufacturers that focus on organizing existing data into well-structured Medical Device Files and Design and Development Files, while clearly linking design decisions, risk controls, production evidence, and post-market feedback, will be best positioned to meet FDA expectations.

QT9 QMS can help customers meet new documentation expectations with centralized, simplified approval routings, electronic signatures, automated versioning and built-in integrations with quality events and controls, including CAPA, employee training and audit trails.