The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of 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 of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.
Overview of 21 CFR part 820
The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.
Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.
Subsection j) of 21 CFR part 820 says:
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.”
DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.
Here are some key interpretations of the DHF guidance that medical device companies should take note of:
A DHF must be maintained for each type of device that you manufacture. For similar versions of the same device, you can include all of the data in a single DHF.
The DHF demonstrates that the device was developed in accordance with both the design plan andthe requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.
The DHF must either contain or reference the necessary documents, which means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.
What belongs in your DHF?
Below, we’ve listed the steps of the design controls process and what documents should be included with each step:
Design input: include your design plan document, developed according to this part.
Design output: Design outputs are the results of the design and engineering efforts. These are normally the final specifications for the device. The outputs are normally documented in models, drawings, engineering analyses, and other documents.
Design review: is a formal review of the medical device design by representatives of each design function participating in the design efforts as well as other interested parties. The design review must be documented in the DHF and include review date, participants, design version/revision reviewed, and review results.
Design verification: is the process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified verification method and verification results.
Process validation: is the process in which the device design is validated using initial/low volume production processes. The purpose of the process validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes.
Design validation: 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 DHF.
Design transfer: Design transfer is the process in which the device design is translated into production, distribution, and installation specifications.
Design changes: Design changes is the process in which the design changes are identified and documented. Also known as engineering change or enterprise change.
FDA Staff (October 7, 1966). “Part 820 ”. Federal Register. 61 (195): 52657. ISBN9781932074109. Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide. Washington, DC: Washington Business Information. p. 52657. ISBN1932074104.