Q: My colleagues and I are having a discussion about design changes. We have characterized a material change to our medical device and have confirmed there’s no impact to any of the product’s design inputs or outputs. In this case, do we still have to formally perform Design Verification and Validation? Or is our evidence of “no impact” from the change enough to satisfy FDA’s requirements?
A: All design changes must be verified and validated, unless you can document that verification alone is appropriate — which it appears you’ve done in this case.
If you have fully documented your characterization studies and your impact analysis, you have performed design verification. Based on that data, you then can decide design validation (performance, functionality and usability, etc. testing) is not required.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You always should do verification for all design changes, as well as perform an impact analysis.[/pullquote]
Let’s review the steps: You always should do verification for all design changes, as well as perform an impact analysis. Also, you always should demonstrate the correctness or appropriateness of every design output specification.
What’s not always required is performance and functionality testing to prove that — given the new output specification — the new finished device will perform and function as intended as well as meet your user’s needs.In this case, your analysis has determined the new material output specifications have no adverse impacts to the other design inputs or outputs associated with this device.
So, based on what you’ve told me, you’ve performed design verification and have a scientific justification for not doing design validation. Just be sure your characterization and analysis of design changes are well documented, even if done via some sort of design or peer review process.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and lead instructor for EduQuest’s 16-hour “Design Control for Medical Devices” training class)