EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, EduQuest’s staff provides insight into proper protocol for control and documentation of device design changes.
Question: Regulation 21 CFR Part 820.30(i), which outlines FDA’s requirements for design changes, doesn't say anything about design planning or design inputs.
As a result, some of my colleagues argue that these elements don’t need to be addressed or documented during design change. How would FDA view this interpretation?
Answer: Your colleagues’ interpretation is wrong. These elements still need to be included, but you can do them in different ways.
Practically speaking, any design change is itself a design effort, and all design efforts must conform completely with the Design Control requirements under the entire 21 CFR Part 820.30 rule.
As you know, during your initial device design you must have a design plan and design input requirements that are documented, reviewed and approved. In initial design, you will likely have changes to various design outputs. These changes should be documented.
During the verification phase, your change control can be as simple as having document revision control and approval via some sort of design review (peer or otherwise). Then, as you begin to finalize the design outputs, your level of change control should be greater. Changes made at this point must be verified (at a minimum) and may need to be validated, depending on what is being changed and how much validation has already been done.
Your change documentation here should be some sort of change request with approval. In addition, you should have documentation to show that various design input and output documents have been revised as applicable. Also, you should document the verification of the change and any required validation activity.
As to post-design, a change request at this point acts as the “design plan” for that change. This is especially true for a design change made after the product is in commercial production.
Any change to a commercially distributed device must be assessed for its effect on the physical design of the device. If it does—or if you don’t know—then that change should be processed as a design change.
At this point, design input requirements usually remain the same as those used for the initial design of the device. But if a new change affects initial design input requirements, then obviously your design input documentation must be revised, reviewed and approved once again.
If the post-design change requires you to follow your overall corporate design and development process and cannot be completed via an engineering change process, then you should follow your corporate process and its required level of documentation, including creation of a new or revised design plan for that design project.
Again, you should update your design input requirements documentation as needed.
If you’re looking at a post-design change made solely through an engineering change, then the change request becomes your new plan and you should update design inputs or outputs as required by the change.
Approval of the change request becomes your initial design review. The engineering change order should detail how you met your plan (the change request) and should include all updated documentation, including:
- Verification activities done to prove that new outputs continue to conform (are appropriate) to the existing design inputs;
- Validation activities done to prove that the new design still meets user needs and intended uses; and
- Regression analysis or testing activities done to prove that the change did not have a negative impact on any other part of the design.
If you determine that no validation activities are required, you should provide scientific rationale or justification to support that decision.
Your change documentation must also include all design transfer documentation. If this is done through a manufacturing location engineering change system, then you need to reference the documentation showing that the new design has been adequately transferred into the production environment.
Review and approval of the engineering change order will serve as your final design review and will allow you to release the change to commercial production and distribution.
Last but not least, all changes must be linked either logically or physically to the Design History File for the device or device family.