This is probably the most frequently asked question by start-up companies. They hear lots of things – both good and bad – about the preSub or Q-Sub process. I have personally heard former FDA personnel – who have moved on to consulting roles – speak about pre-submissions, and they seem to have a negative opinion of the value of the process.
Many of these ex-FDA staffers worked for the agency when pre-submissions were known as a pre-IDEs, and were used primarily for dialogue with the FDA about investigational device exemptions prior to a clinical trial. Since that time, pre-IDEs came to be used for other types of dialogue and, in the spirit of transparency and collaboration, became feedback on medical device submissions in final guidance from the agency, drafted in 2012 and finalized in 2014 (and then updated in 2017).
My own experience with the pre-submission process has been very good; I have seen two very positive outcomes. First, preparing the preSub package requires a company to gather information and describe the device and its use for the FDA. This often reveals gaps in understanding that can be remedied earlier in the development process.
The second advantage of putting the preSub together is the careful formulation of questions for the FDA. Remember, we don’t ask open-ended questions like, “What kind of clinical trial would the FDA like to see for this type of product.” Rather, do the work of crafting a draft clinical plan to include in the preSub package, and ask the FDA if they agree with the plan. The more we can “think like the regulators,” the better chance we have of an expedient clearance or approval.
