This month, the FDA replaced its 2018 Pre-RFD guidance with significant updates that impact how manufacturers prepare and submit requests.
High impact changes
The vague “request a meeting” approach is gone. FDA now distinguishes between two structured meeting types: informational meetings (pre-submission, 6-week timeline) and explanatory meetings (post-assessment, 2-week timeline). Your SOPs will need updating.
Content requirements have also tightened. FDA now requires exact concentrations (no ranges accepted) and explicitly states what NOT to include (biocompatibility, human factors, electrical safety testing). Existing templates will need revision.
Medium impact changes
Responding to OCP information requests now requires three specific documents: a Q&A document, a track-changes version, and a clean version of your revised Pre-RFD.
Administrative updates
Email submissions only, a 10-day completeness review (extended from 5 days), and a recommended 15–20 page limit. FDA’s burden estimate has nearly doubled to 24 hours per submission, reflecting the increased detail requirements.
Bottom line: These changes push for more efficient, focused submissions but require updates to your internal processes, templates, and staff training.
If you have any regulatory questions, let us know via info@eumediq.eu.