DHF Requirement for Class I Medical Device
A Design History File (DHF) documents the design and development history of a medical device. However, not every Class I medical device is subject to the same design control requirements.
For manufacturers selling medical devices in the United States, understanding when design controls apply is important for determining whether a formal DHF is required and what design records need to be maintained.
There is also an important regulatory update to consider. The FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026, replacing the former Quality System Regulation framework in 21 CFR Part 820 and incorporating ISO 13485:2016 by reference.
This means manufacturers reviewing their DHF and design control processes should assess them against the current QMSR framework rather than relying only on the older version of 21 CFR 820.30.
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What Is a Design History File (DHF)?
A Design History File is a collection of records that demonstrates how a medical device was designed and developed.
In practical terms, the DHF provides documented evidence that the manufacturer’s design and development activities followed the established procedures and requirements applicable to the device.
A DHF may include or reference records related to:
- Design and development planning
- Design inputs
- Design outputs
- Design reviews
- Risk management
- Design verification
- Design validation
- Design transfer
- Design changes
- Supporting test and evaluation records
The exact structure and contents of a DHF depend on the manufacturer’s QMS, device, design process, and applicable regulatory requirements.
Is a DHF Required for a Class I Medical Device?
Not necessarily.
The fact that a device is classified as Class I does not by itself determine whether design controls apply.
FDA states that manufacturers of Class II and Class III devices, as well as certain Class I devices, are required to follow design controls. Class I devices subject to design controls include devices automated with computer software and certain specific devices identified by regulation.
Therefore, the correct approach is:
Determine the device classification and applicable exemptions first, then determine whether design and development controls apply.
Manufacturers should not assume that every Class I device is either completely exempt from design controls or automatically requires the same level of design documentation as a Class II or Class III device.
Which Class I Devices Are Subject to Design Controls?
FDA identifies certain Class I devices that are subject to design controls.
These include:
- Devices automated with computer software
- Catheter, tracheobronchial suction
- Glove, surgeon’s
- Restraint, protective
- System, applicator, radionuclide, manual
- Source, radionuclide teletherapy
FDA also explains that Class I devices that are automated by computer software are subject to design controls.
The applicable classification regulation should always be reviewed for the specific device before determining the regulatory documentation requirements.
What Changed With FDA QMSR in 2026?
The FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026.
The QMSR amended 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. The FDA now uses an inspection process aligned with the QMSR rather than the previous QSIT inspection approach.
This is particularly important for manufacturers reviewing older DHF procedures and templates.
The transition does not mean that design and development documentation is no longer important. Instead, manufacturers should ensure their quality system and design and development processes align with the current QMSR and applicable ISO 13485 requirements.
FDA has also stated that investigators may review QMS records created before February 2, 2026, as part of inspections conducted under the QMSR.
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What Should a DHF Contain for a Class I Device?
When design controls apply, the design history should provide a clear and traceable record of the development process.
Depending on the device and QMS, relevant records may include:
1. Design and Development Plan
The plan defines how the design and development process will be conducted.
It may identify:
- Development stages
- Responsibilities
- Required reviews
- Verification and validation activities
- Design interfaces
- Applicable standards and regulatory requirements
2. Design Inputs
Design inputs establish the requirements the device must meet.
Examples include:
- Intended use
- User needs
- Performance requirements
- Safety requirements
- Applicable regulatory requirements
- Applicable standards
- Environmental requirements
Design inputs should be clear, measurable where appropriate, and traceable to the resulting design outputs.
3. Design Outputs
Design outputs define the final design specifications and information needed to manufacture or control the device.
Examples may include:
- Engineering drawings
- Product specifications
- Material specifications
- Software specifications
- Manufacturing specifications
- Packaging specifications
- Labeling specifications
4. Design Reviews
Design reviews provide documented evidence that the design was evaluated at appropriate stages of development.
Records can include:
- Review date
- Participants
- Design information reviewed
- Identified issues
- Decisions
- Required actions
- Approvals
5. Risk Management Records
Risk management should identify hazards, evaluate risks, define risk controls, and assess whether controls are effective.
For many medical devices, ISO 14971 is an important standard for medical device risk management.
Risk management should also remain connected to design inputs, outputs, verification, validation, and design changes.
6. Design Verification
Verification demonstrates that design outputs meet specified design inputs.
Depending on the device, this may involve:
- Bench testing
- Performance testing
- Software testing
- Dimensional testing
- Electrical testing
- Mechanical testing
- Laboratory testing
The appropriate testing depends on the device’s characteristics and intended use.
7. Design Validation
Validation provides evidence that the resulting device meets user needs and intended uses under defined conditions.
Validation activities may involve simulated-use testing, clinical evaluation, usability activities, or other appropriate methods depending on the device.
8. Design Transfer
Design transfer demonstrates that the approved design has been adequately transferred into production.
Relevant records may include:
- Manufacturing specifications
- Work instructions
- Production procedures
- Process validation
- Inspection requirements
- Acceptance criteria
9. Design Changes
Design changes should be documented, reviewed, and evaluated for their impact.
Change records may include:
- Description of the change
- Reason for the change
- Risk assessment
- Verification or validation requirements
- Regulatory impact
- Approval
- Implementation date
DHF vs Device Master Record vs Device History Record
These files are often confused, but they serve different purposes.
| Record | Primary Purpose |
|---|---|
| DHF | Documents how the device was designed and developed |
| DMR | Defines the specifications and procedures required to manufacture the device |
| DHR | Provides evidence that a specific production batch or unit was manufactured according to applicable requirements |
Understanding this distinction helps manufacturers organize their QMS documentation and maintain appropriate traceability.
What If a Class I Device Is Exempt From Design Controls?
A Class I device may be exempt from certain requirements depending on its specific classification and applicable FDA exemptions. FDA advises manufacturers to verify the requirements for the specific device because exemptions can have limitations.
An exemption from a particular requirement does not mean that the manufacturer can disregard all quality, safety, recordkeeping, labeling, registration, or other applicable regulatory obligations.
FDA states that general controls apply to Class I devices, unless a specific exemption applies.
Therefore, manufacturers should evaluate the complete regulatory profile of the device rather than using the Class I classification alone to determine documentation requirements.
Best Practices for Class I Medical Device Design Documentation
A practical DHF management approach should include:
1. Determine regulatory applicability first
Confirm the device classification, product code, exemptions, and whether design controls apply.
2. Establish a documented design process
Define responsibilities, development stages, reviews, and required records.
3. Maintain traceability
Connect user needs and design inputs to outputs, risk controls, verification, and validation.
4. Control design changes
Document the reason, impact, risk, verification or validation, and approval of changes.
5. Maintain controlled records
Use document control and version control to prevent obsolete records from being used.
6. Review the QMS against current FDA requirements
Since QMSR became effective in 2026, manufacturers should ensure applicable procedures reflect the current regulatory framework.
How Operon Strategist Can Help With DHF Compliance
Operon Strategist supports medical device manufacturers and startups with design and development documentation and regulatory compliance.
Our services include:
- DHF preparation and gap assessment
- Design and development documentation
- Design control process development
- Risk management documentation
- Design verification and validation support
- Design transfer documentation
- Design change documentation
- ISO 13485 QMS consulting
- FDA QMSR compliance support
- FDA 510(k) regulatory consulting
- Medical device manufacturing setup consulting
Our team can help assess existing design documentation, identify gaps, establish traceability, and organize design records into an audit-ready documentation structure.
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FAQ's
Is a DHF mandatory for all Class I medical devices?
No. DHF and design control requirements depend on the specific device and applicable exemptions. Certain Class I devices are subject to design controls, while others may be exempt from particular requirements.
Does a Class I medical device need design controls?
Not every Class I device. FDA requires design controls for Class II and Class III devices and certain Class I devices, including software-automated Class I devices and specific device types identified by regulation.
Is 21 CFR 820.30 still applicable in 2026?
The FDA’s QMSR became effective on February 2, 2026, amending 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. Manufacturers should therefore use the current QMSR framework when assessing their quality and design processes.
Which are the top parks?
The FDA’s QMSR became effective on February 2, 2026, amending 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. Manufacturers should therefore use the current QMSR framework when assessing their quality and design processes.
Does FDA QMSR replace the DHF?
QMSR does not mean that manufacturers can stop maintaining appropriate design and development records. Where design and development requirements apply, manufacturers need documented evidence demonstrating compliance with the applicable requirements.