The United States Code of Federal Regulations Title 21 defines the DHF and its purpose for medical device manufacturers.
According to Section 820.3(e) of the Federal Regulations:
“Design History File (DHF) means a compilation of records which describes the design history of a finished device.”
Similarly, Section 820.30(j) of the Regulation states the following regarding DHF:
“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.”
Both the requirements, i.e., Formal Design Control and Design History File (DHF), are part of GMPs. FDA constituted both of these requirements in 1996-1997. Because of the regulations, medical device manufacturers must fulfill these requirements.
How DHF Helps Medical Device Manufacturers?
These requirements help companies in retention of their Intellectual Property (IP) by:
- Proper documentation of development and changes
- Creation of false start records.
It can prove to be a valuable training tool for engineering, manufacturing, QA, and marketing personnel.
Contents of a Design History File (DHF)
The completed Design History File (DHF) contains the following:
A detailed design and development plan that specifies design tasks and deliverables as “living document.”
Design Input and Output Documents
It has approved copies of design input and design output documents.
It also contains documentation of design reviews.
Documentation of Verification and Validation
It has documentation of verification and validation.
Controlled Design Documents and Change Control
Where applicable, DHF contains copies of
- Controlled design documents
- Change control rationale
Management of a DHF
A medical device manufacturer can take the following steps in managing his devices’ DHF:
Witnessing the Development Documentation-Step 1
Where appropriate, the development documentation must be adequately witnessed as it can help in supporting patent claims.
Learning about the Manufacturer’s Rights-Step 2
The design and development documents should clearly specify:
- The manufacturer’s right to design information
- Defining and establishing standards for the form
- Content of the design documentation.
This step also includes custom software.
Maintenance of the DHF-Step 3
- A single project file can maintain a specific amount of basic information in a specified location
- This information can be stored in the DHF document having pointers to other supporting documents that are not directly included in the DHF. This also includes dates and revision numbers.
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