What is Going on with the Pre-Submission Program?

It seems like every other discussion I have these days someone asks, “what is going on with the pre-submission program?”  “I heard CDRH isn’t reviewing pre-submission,” or “I heard FDA is only providing written feedback and not holding meetings.”  So, we thought it was time for a post dedicated to every device manufacturer’s favorite early interaction process – the pre-submission program.

This spring, CDRH provided an update on how the pandemic had affected the Center’s workload (announcement here).  The announcement indicated that OHT7 (formerly OIR) has been and would continue to be declining most pre-submissions.  The only pre-submission that this Office have been and would be continuing to review are those “related to COVID-19, companion diagnostics, a breakthrough designation request, or have a significant public health impact.”  In our experience, OHT7 has been reviewing pre-submissions for these product types.  Companies with non-COVID diagnostics should carefully consider whether their tests fit within one of these categories.

For pre-submissions in other Offices, the announcement stated that CDRH “anticipate[s] pre-submissions . . . be[ing] completed within 120 days, rather than the usual 70 days.”  In our experience, these estimates have held true.  Offices, other than OHT7, have continued to review pre-submissions and hold teleconferences, when requested.  These meetings are often taking longer than the pre-pandemic 70-day timeline, however.  In our experience, these delays, sometimes, come at the last minute just before a meeting has been scheduled.  Thus, sponsors will need to remain flexible even when a meeting has been scheduled.  We have also noticed, in some circumstances, Offices declining to answer all of a sponsor’s questions noting that, for example, a separate pre-submission was required for a question regarding study risk when the pre-submission is seeking input on the study design.  These efforts appear designed to limit the focus of pre-submissions.

Bottom line – the pre-submission program is still running just with some minor modifications.  Meetings are being held – virtually still.  In light of Omicron, it is unclear when in-person pre-submissions will return.  We confirmed that there have been no other changes to the Center’s policies.  Sponsors should be aware that CDRH is doing its best to remain flexible with its Divisions given their workload and many Divisions are currently understaffed due in part to departures and/or resources having been pulled to other Divisions.