The Design History File is the final component of the design control process. The FDA defines a Design History File (DHF) as “a compilation of records which describes the design history of a finished device”. While there are not any specific requirements in either ISO 9001 or ISO 13485, a DHF is required by the FDA in order to market a medical device in the United States. You must create a separate DHF for each medical device you manufacture.
The intent of a DHF is to make sure the manufacturers have access to the development information when it is needed. This is a place where you show all of the linkages and relationships between the design controls – it’s where you show traceability of all the controls throughout the entire design process. All of the design information is not required to be stored in one location, though it will make it easier to locate. There aren’t any specific requirements for where the DHF is kept, or how it is organized.
There are two aspects of the Design History File that you will want to have identified, as the FDA inspector will be looking for these to be in place. The first is to define which records will comprise the DHF. These records should include:
- Design Plan
- User Needs
- Design Inputs
- Design Outputs
- Risk Analysis (including hazard identification)
- Human Factors Analysis
- Design Verification, with acceptance criteria
- Design Validation, with acceptance criteria
- Design Changes
- Design Reviews
- Design Transfer
The second aspect is to identify when the DHF begins and ends. The best “end” of a DHF is to close it when you receive your 510(k) clearance letter from the FDA. You definitely do not want to keep the DHF open for the life of the product. The last three steps, or items, to wrap up the design transfer process will be:
- Initiate a Device Master Record (DMR) – creating this as an index is considered a best practice.
- Initiate a Post-Market Surveillance plan for the new product – this should include an updated risk management plan
- Add the 510(k) approval letter to the DHF
At this point you can create the DMR Index. The advantage to closing, or ending, the DHF after the transfer is completed is to facilitate the tracking of changes. The initial revision of the DMR is “A” or “1” (depending on your revision system). Every time a design change is made, at least one of the documents in the DMR will need to be revised. Therefore, the revision history of the DMR Index will identify each change. As a note, not every change is worthy of documenting in your DHF. To decide if the change should be included, ask yourself these questions: Did the design plan change; did a design input change; did a design output change; was the risk analysis affected? If the answer is yes to any of the four questions, then the change is significant enough to include documentation in the DHF.
The Design History File can be either a collection of the actual documents generated in product development, or an index of the documents and a reference to their storage location. In order to demonstrate that the design was developed according to the FDA requirements, the DHF may include:
- The detailed design and development plan specifying tasks and deliverables
- Copies of approved design input and output documents
- Documentation from design reviews
- All validation and verification documentation
- Change control rationale and records
It is recommended that, where appropriate, development documentation should be properly witnessed. If that happens, then the DHF documentation may also serve in supporting patent claims.
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