MDUFMA guidances
This article was originally published in The Gray Sheet
Executive Summary
Expedited review, PMA user-fee refunds and multiple device bundling are addressed in three separate guidances related to the Medical Device User Fee & Modernization Act - "1Expedited Review of Premarket Submissions for Devices," "2User Fees and Refunds for Premarket Approval Applications" and "3Bundling Multiple Devices or Multiple Indications in a Single Submission" - all posted Nov. 21 on FDA's website, and open for public comment...