November 2025

Continuing our series debunking common misconceptions in Regulatory Affairs. The myth: Many MedTech manufacturers treat gap analyses as administrative exercises. Documents created to satisfy auditors or tick a compliance box. They’re often seen as retrospective paperwork rather than proactive tools. The reality: A well-executed gap analysis is a strategic planning instrument, not documentation for its […]

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.