Design History File Unpacked: Part 1 of 3 – Origins, Obligations & What Every Med-Tech Team Must Archive

The beginning

The Food and Drug Administration (FDA) quality system requirements for all medical-device companies are documented in the Code of Federal Regulations under 21 CFR Part 820.

In 1990, the FDA mandated the design history file (DHF) as part of the Safe Medical Devices Act. It contains all product-development documentation pertaining to a finished medical device. The DHF is the final step in the design-controls process required by 21 CFR Part 820.

Overview of 21 CFR Part 820

The FDA requires each medical-device company to establish and maintain a quality system that meets the regulations and is appropriate for the device it manufactures. Different device classes may have different requirements; for example, most Class I devices are exempt from design controls, but the overall quality-system guidelines must still be satisfied before the device can be sold in the United States.

Companies can view the quality-system regulations as their “admission ticket” to the U.S. medical-device market.

DHF

Subsection (j) of 21 CFR Part 820 states:

“Design history file. 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 plan and the requirements of this part.”

The DHF is primarily an organizational tool that shows the design-controls process was properly followed and documented. While most regulations focus on policies and procedures for quality standards, design controls are a core part of the overall quality-management system (QMS). A complete, accurate DHF can help during an FDA audit.

Key interpretations of the DHF guidance:

• Maintain one DHF for each device type; similar versions may share a single file.
• The DHF must demonstrate that development followed both the approved design plan and 21 CFR Part 820 requirements; include the plan in the file.
• The file may either contain the required documents or reference them through a master index.

What belongs in your DHF?

Below are the design-controls steps and the documents that typically accompany each one:

Further reading:

• FDA official site
• WHO medical device resources

1. Design input: include your design plan document, developed according to this part.
2. Design output: the results of design and engineering efforts, typically the final device specifications, documented in models, drawings, engineering analyses, and other records.
3. Design review: a formal review of the medical device design by representatives of each design function and other interested parties. It must be documented in the DHF with the review date, participants, design version/revision reviewed, and review results.
4. Design verification: confirmation that the design output conforms to the design input, demonstrating that the specifications are correct. It must be documented in the DHF with the verification date, participants, design version/revision verified, verification method, and verification results.
5. Process validation: validation of the device design using initial/low-volume production processes to confirm that the design functions according to design inputs under normal production conditions rather than prototype conditions.
6. Design validation: performed under defined operating conditions on initial production units, lots, or batches (or their equivalents) to ensure devices meet defined user needs and intended uses. It includes testing under actual or simulated use conditions, software validation, and risk analysis where appropriate. Results, including design identification, method(s), date, and individuals performing the validation, must be documented in the DHF.
7. Design transfer: the process of translating the device design into production, distribution, and installation specifications.
8. Design changes: the process of identifying and documenting design changes, also known as engineering or enterprise changes.

References

1. Harnack, Gordon (1999). Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.
2. FDA Staff (October 7, 1996). “Part 820”. Federal Register. 61 (195): 52657. ISBN 9781932074109. Retrieved January 13, 2017. Also available in hardcopy as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN 1932074104.

Further reading

• FDA official site
• WHO medical device resources