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Saving Unnecessary Costs on an FDA Revalidation Request


A pharmaceutical client added an exhaust sound suppressor to their autoinjector to quiet the device. The FDA thought that this fundamentally changed the device by removing an auditory signal of injection completion and wanted revalidation of the new design for usability. They came to us to design the revalidation study.


By reviewing the existing risk analyses and past usability test results along with academic literature citations on behavioral principles, our behavioral analysis experts determined that the “auditory cue” did not impact injection behavior because of the speed of the injection process. Human reflexes are not fast enough to stop the process in time to avoid a full injection, with or without an auditory cue. We wrote a white paper to justify not doing a new user study.


As a result of our research, the client was able to convince the FDA that the device did not require revalidation. This saved considerable time and money and avoided a four to five month delay of their product launch that would have resulted with completion of a full summative study with three user groups.