The Design History File (DHF) is a structured document that captures the entire design and development journey of a medical device. It serves as a formal record, ensuring all the necessary design and development processes are documented in an organized manner
What Are the FDA Guidelines For DHF?
The design history file requirements are given in 21 CFR Part 820.30, which contains the regulations for the design controls process. We have to refer to its subsection (j) for the specific text on Design History file (DHF). According to subsection (j) of Design history file. Every manufacturer of medical devices has to prepare and maintain a DHF for each type of medical device. The Design History file should contain all records required to demonstrate that the Device design was developed in accordance with the approved design plan and the requirements of this part.
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Some Key Interpretations of the DHF Guidance are as Follows:
- Design history files are important to maintain for every type of device that you manufacture. If you make similar versions of the same device and the designs are the same, you can include all of the data in a single DHF.
- The Design History file states that the device which is developed is in accordance with both the design plan and the requirements of this part. Design plan should comply 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 one could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials. In the latter case, the materials would be stored in a software QMS and the DHF would be used to access them.
What Should Your Design History (DHF) File Contain?
The Design History file should contain all of the documentation created during the product development phase of your medical device. Following are design controls process which will help you understand what documents are required for DHF. Each step of design control processes generates its own documentation.
Design and development planning – include your design plan document, developed according to this part.
Design input – Design input includes procedures for establishing design input that addresses the intended use and user needs
Design output – Design Output includes the procedure for defining and documenting design output in compliance with this part, and the approved design output documentation itself.
Design review – Design Review contains procedure for conducting reviews of your design process and any documentation related to the reviews that were conducted.
Design verification – Design Verification includes a document describing your design validation process and the approved results of the design validation.
Design validation – Design validation consists of specific procedure and testing conditions used for design validation, as well as the approved results of the design validation process.
Design transfer – Design transfer includes the documented product specifications that are developed in compliance with this part and a description of the process used.
Design changes –Design changes contains documented design change process and documentation pertaining to any design changes that have taken place.
As per the section 820.30 Design controls:
The manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of 21CFR 820.30 shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
Below are the class I devices ,which are subject to design controls:
(I) Devices automated with computer software; and
(II) The devices listed in the following chart.
| Section (21 CFR) | Device |
| 868.6810 | Catheter, Tracheobronchial Suction. |
| 878.4460 | Glove, Surgeon’s. |
| 880.6760 | Restraint, Protective. |
| 892.5650 | System, Applicator, Radionuclide, Manual. |
| 892.5740 | Source, Radionuclide Teletherapy. |
How Much Less Documentation Is Required for the Design of a Class I Device Compared With a Class Ii Device?
There is no one answer for this question to make it less difficult. You can simply say that instead of 0% (Yes, a DHF is required) of 100% (No DHF required), the answer is that you need 33% less documentation for the design of a Class I device. There are various types of class I Medical devices; some of them may require design control and some may not. Despite of lack of design control manufacturer still has to still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs), and design changes may still require revalidation before implementation
Why is a DHF Required for Class II, but Not for Class I?
Class I medical devices are subject to the FDA’s general controls and “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class I devices have a low impact on patients’ overall health and do not come into contact with their organs, the central nervous system or the cardiovascular system. These devices are simple devices that are already on the market and have a history of clinical safety. Class II devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a higher risk for Class II devices. When you design a Class I device, you still have to determine what your design specifications will be. Again, you don’t need:
1) To review & approve design inputs
2) a procedure to document your design process
3) document formal design reviews
4) To create a design plan.
According to FDA, a design transfer procedure should include at least three basic elements:
- Design and development procedures should consist of a qualitative assessment of the completeness and adequacy of the production specifications.
- Procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
- Procedures should ensure that only approved specifications are used to manufacture production devices.
The first of these basic elements is not required for Class I devices because product specifications for most Class I devices are simple. The two requirements are fundamental principles of document control and configuration management. Therefore, you need a design transfer procedure for Class I medical devices, but you don’t need to include the first element that relies upon design and development procedures.
If you have a Class I device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you should validate and re-validate the technique in accordance with 21 CFR 820.75. Class I products also require a device master record (DMR) in accordance with 21 CFR 820.181.
What is Not DHF Required?
Needed for Class I (67%)
- Approved Design Outputs
- Labeling Procedure and Approved Labeling
- Sterilization Validation Protocol and Report
- Design Transfer Procedure
- Approved DMR
- Design Change Procedure
- Needed for Class II and Class I requiring Design Controls (100%)
- Design Control Procedure
- Design Plan
- Approved Design Inputs and Outputs
- Labeling Procedure & Approved Labeling
- Sterilization Validation Procedure and Protocol and Report
- Design Transfer Procedure
- Evidence of at least 1 Design Review
- Approved DMR
- Design Change Procedure
Therefore, although you do not technically have to have a DHF for a Class I products, the difference between the two categories is the following elements:
- Design Control Procedure
- Design Plan
- Approved Design Inputs
- Evidence of at least I Design Review
When an FDA inspection occurs, the investigator will review your design control procedure and then audit your DHF in accordance with your design plan. When you have a Class I device, you are not typically inspected unless there is a problem. When ORA inspectors perform an inspection for Class I devices, the inspector looks for evidence of items in the first list. Team of Operon Strategist a Medical device design consultant helps you to compile your DHF in time for the audits. The creation of DHF becomes easy with us , as we have an expert team of Medical device regulatory consultant who keenly work for the requirement of the manufacturer. Contact us now to ensure a smooth DHF compilation process and successful audits.
