The regulatory submission process can leave most anyone depressed. But if your incomplete and/or ineffective design controls are to blame, you’ll be stuck in your black mood for a long, long time waiting for your submission to be approved.
Depression is the fourth stage of regulatory grief, but it really doesn’t have to be that way. You can easily correct design control problems with a little common sense and close attention to the applicable standards. But there are also some things you shouldn’t do when documenting your design controls:
Don’t ignore the latest standards. The FDA won’t and they will expect you to address them in your submission.
Don’t use old data. This will wave a huge red flag in front of your FDA reviewer.
Don’t adjust your standards to align with your data. The FDA is sensitive to data that is too clean, thanks to the many examples of “perfect” devices that caused serious injury or death in the field.
Don’t delete data that doesn’t support your hypothesis. See the #2 and #3 above.
Also, don’t make the mistake of thinking that your patent equals your design controls. This will make your regulatory consultant reach for the antacids on a regular basis.
Unlike a patent, the phases of proper design control are not discrete, one-time events. They are an overlapping series of activities spanning the entire development timeline of the project. Each of these phases is a component of your risk management file, and each is a living thing that needs care and maintenance and feeding if you want to keep the FDA off your back.
User Needs – Design Inputs – Design Outputs – Design Verification – Design Validation – Design Tranfer to Production
Still confused about design controls? Still depressed about the status of your FDA submission?
I am a certified regulatory grief counselor, and I can help: https://leanraqa.com/