Mastering PRESUB: FDA Pre-Submission for the MedTech Industry with Michelle Lott, RAC (Webinar)

Welcome to the MedTech Leading Voice replay of our masterclass on mastering the FDA's pre-submission process (Q-submission) for the MedTech industry, presented by Michelle Lott, RAC, Regulatory Strategist, Principal, and Founder of leanRAQA.

Recorded: May16, 2024

This session is designed to help small to medium-sized MedTech companies streamline their product's regulatory process efficiently and economically.

Timestamps/Chapters:
[00:00] - Introduction and Welcome
[00:41] - Overview of Pre-submission Masterclass
[01:52] - Importance of Pre-submissions
[04:19] - Key Insights on Regulatory Strategy
[08:12] - Interactive Poll: Planning a Pre-submission
[09:23] - Crafting Effective Questions
[13:18] - Feedback Options: Written vs. Teleconference vs. In-person
[16:12] - Introduction to Prestar Template
[20:46] - Interactive Poll: Experience with Pre-submissions
[22:03] - Prestar Template Advantages and Challenges
[27:10] - Timeline for Pre-submissions
[30:18] - Meeting Management Tips
[32:31] - Common Mistakes to Avoid
[37:58] - 513(g) Requests for Information
[44:21] - Breakthrough Devices and Safer Technologies Program
[52:52] - Strategic Advantages of BDD and STeP
[54:53] - Lessons Learned and Multiple Pre-subs
[58:34] - Utilizing FDA Guidance and Verbiage
[01:03:41] - Helpful Resources and Tools

Additional Resources:
19 Burning Questions and Answers about FDA Presubmission:
PDF Slide Deck:   / aqf1d9oj_pee4g  
Pre-submission Cheat Sheet:   / aqghjpa0ubaqla  

Thank you for watching!
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