FDA issued a final version of its guidance “Requests for Feedback on Medical Device Submissions:The Pre-Submission Program and Meetings with Food and Drug Administration Staff”. The document is dated Feb 18, 2014. The link provided contains slides from a presentation by Soma Kalb from FDA’s Offiice of Device Evaluation and Elizabeth Hillebrenner from FDA’s Office of In Vitro Diagnostics and Radiological Health.
Keyword: Presub.