Preparing Your Pre-Submission with the Content FDA Wants to See

Global Medical Device Podcast · 23 Jun 2021 · 36m · Episode 216

What this episode covers

Mike Drues, a regulatory consultant for Vascular Sciences, explains the strategic preparation of FDA Pre-submissions (Q-submissions) to mitigate the high first-time rejection rates of 510(k) and PMA applications. He argues that companies should treat the FDA as an equal partner rather than a teacher, using Pre-subs to justify both the proposed regulatory pathway and the testing matrix. Drues emphasizes that success requires leading the witness by framing questions to demonstrate why a specific approach is correct, rather than simply asking for approval. The episode highlights that ignoring this strategic communication often leads to costly delays and major deficiency letters.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: Vascular Sciences, Green Light Guru
Also: FDA, 510(k), PMA, De Novo

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The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.

Preparing Your Pre-Submission with the Content FDA Wants to See

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

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256 - The New FDA Inspection Playbook: Where to Start with QMSR

106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson