FDA's New PMA Electronic Submission Template: Draft Guidance Explained

Medical Device Global Market Access · Sep 23, 2026 · 4m

This episode details the US FDA's new draft guidance on an electronic submission template for Premarket Approval (PMA) applications, issued on September 17, 2026. We explore which submission types are covered, such as Original PMAs and Panel-Track Supplements, and explain how the template aims to improve submission consistency and review efficiency for high-risk Class III medical devices. We also outline practical steps for regulatory and quality teams to prepare for this upcoming change. Key Questions: - What is the new FDA draft guidance on PMA electronic submissions issued in September…