Design History File (DHF) Management Methods

This article explains the proper management methods for the Design History File (DHF), as many medical device companies misunderstand how DHFs should be managed.

In my experience with numerous medical device companies, documents are often filed in binders organized by individual design documents. However, this management approach does not align with the true purpose of the DHF.

Why DHF is Necessary

The FDA’s Quality System Regulation (QSR) under 21 CFR Part 820 requires the creation of a Design History File (DHF) as part of design controls. In ISO 13485, a similar requirement is specified under the term “Design and Development File.”

As the name suggests, the DHF is a compilation of design history. The reason a DHF is necessary is that even for the same product, the design may have changed between units shipped five years ago, three years ago, and those currently being shipped.

For example, consider a repair request due to device failure. If the product was shipped five years ago, failure to quickly retrieve the complete set of design documents from that time would make it difficult to investigate the cause of the failure. Additionally, when adverse events are reported during post-market surveillance activities, the ability to rapidly verify the design state at the time of product manufacture is essential for root cause analysis and implementation of appropriate corrective actions.

Therefore, the DHF must file all design documents from each design change by “threading them together” – essentially taking a snapshot of the latest design documents at that particular point in time.

FDA Requirements for DHF Management

Below are the documentation requirements for DHF in the FDA QSR:

820.30 Design Controls

(e) Design Review

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are conducted at appropriate stages of the device’s development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (DHF).

(f) Design Verification

Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the design history file (DHF).

(g) Design Validation

Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the design history file (DHF).

Therefore, according to the FDA QSR, the three design documents that must be documented in the DHF are:

1. Results of Design Review
2. Results of Design Verification
3. Results of Design Validation

However, in many medical device companies, the results of Design Verification and Design Validation are necessarily included as inputs to Design Review.

In other words, the FDA QSR requirement can be understood as filing the results of Design Reviews in the DHF.

For a given product, design reviews typically progress as DR0 ⇒ DR1 ⇒ DR2 ⇒ DR3. In the DHF, all design documents submitted to each Design Review, along with their results, should be bundled together (like taking a snapshot) and filed.

Generally, Design Reviews are conducted at the end of each design and development phase (serving as gate reviews for phase transitions). Therefore, by filing a complete set of Design Review results in the DHF, the design control history is appropriately recorded.

Practical DHF Management Methods

The DHF does not necessarily need to be physically stored. For example, when managing drawings as CAD data or other electronic records, referencing the storage location of electronic records is acceptable. In recent years, electronic DHF management using electronic Quality Management Systems (eQMS) has become mainstream, facilitating easier document version control and traceability.

In other words, the DHF can be managed as an index, while design documents may be stored separately in binders or as electronic records.

The critical point is that versions from any given time must be retrievable promptly according to design and development progress. This ensures that the exact design state at any point throughout the product lifecycle can be accurately reproduced.

Relationship with ISO 13485 Design and Development Files

ISO 13485:2016 requires the creation of a “Design and Development File” in Section 7.3.10. This is essentially the same concept as the FDA’s DHF, requiring that each medical device type or product family contain or reference records that demonstrate satisfaction of design and development requirements.

ISO 13485 does not use the term DHF but instead uses “Design and Development File,” though the purpose and content are similar. It encompasses records of design and development planning, inputs, outputs, reviews, verification, validation, and change control.

Transition to QMSR (Quality Management System Regulation)

As an important regulatory development, on February 2, 2024, the FDA published a major revision to 21 CFR Part 820, renaming it the Quality Management System Regulation (QMSR). This revision becomes effective on February 2, 2026.

Under QMSR, the majority of subparts (Subparts C through O) of 21 CFR Part 820 have been removed and replaced by incorporation by reference of ISO 13485:2016 (§820.7 Incorporation by Reference). As a result, terms traditionally used in the QSR such as “Design History File (DHF),” “Device Master Record (DMR),” and “Device History Record (DHR)” have been removed from the regulation text and will be replaced with ISO 13485 terminology.

However, this does not mean that the concepts or requirements have disappeared. By satisfying the corresponding requirements in ISO 13485:2016 (such as design and development files), the former DHF requirements are also satisfied. Manufacturers must align with ISO 13485:2016 by February 2, 2026.

The transition to QMSR is expected to promote international regulatory harmonization and reduce duplicate audits by multiple regulatory authorities. However, ISO 13485 certification alone is insufficient, and compliance with US-specific additional requirements such as Unique Device Identification (UDI) requirements and Medical Device Reporting (MDR) obligations remains necessary.

Best Practices for DHF Management

For effective DHF management, the following points should be considered:

First, it is important to establish a systematic document management system from the early stages of design and development. At each Design Review milestone, completely record the design state at that time and create an index for easy future reference.

Next, by integrating design change control with the DHF, clarify which design changes are reflected in which version of design documents. This enables rapid and accurate root cause analysis when post-market quality issues arise.

Furthermore, DHF contents should include documents covering the entire design and development process, such as design plans, design input documents, design output documents, risk management files, Design Review minutes, verification reports, validation reports, and design transfer records.

When utilizing electronic DHF management systems, compliance with related requirements such as 21 CFR Part 11 (Electronic Records and Electronic Signatures) and EU GMP Annex 11 (Computerized Systems) must also be ensured.

Finally, it should be recognized that the DHF is not merely for meeting regulatory requirements, but is also a valuable asset for accumulating product development knowledge within the organization and leveraging it for future product improvements and new product development.

Summary

Proper DHF management contributes not only to ensuring regulatory compliance but also to improving product quality, streamlining post-market surveillance activities, and accumulating organizational knowledge. In anticipation of QMSR implementation in 2026, establishing an effective DHF management system while ensuring consistency with ISO 13485:2016 has become an important challenge for medical device companies.