CDRH released final guidance for device sponsors on requesting feedback or meetings with agency officials ahead of investigational device exemption (IDE) or other marketing submissions under the Q-Submission program.
The program was established in 1995, initially to provide sponsors a way to get FDA feedback on IDE applications prior to submission. Over time, it evolved to include feedback on premarket approvals, humanitarian device exemptions, De Novo requests, and 510(k) submissions, as well as to assess whether a clinical trial requires submission of an IDE, the agency explained.
Q-Sub interactions can include pre-submissions for marketing applications, submission issue requests—usually relating to hold letters—and study risk determinations to assess whether a planned device clinical trial is a significant risk, non-significant risk, or exempt from IDE regulations.
Read the full guidance here: www.fdanews.com/06-06-19-QSubmissions.pdf.