Letter to File 101: Are You Sure You're Preparing Yours Correctly?

This on-demand webinar, hosted by Greenlight Guru, focuses on the critical aspects of preparing a letter-to-file (LTF) for medical device companies. The presentation guides viewers through the process of correctly preparing a letter-to-file to avoid potential regulatory pitfalls with FDA.
Main points covered:
1. Understanding what a Letter-to-File is and when/how it should be used.
2. Insights into the contents of a Letter-to-File and what it should include.
3. Comparing a Letter-to-File with other regulatory submissions like a special 510(k) or PMA supplement.
4. Exploring the use of Letter-to-File for class III PMA devices.
5. Discussing the advantages and challenges of choosing a Letter-to-File over notifying the FDA.
Target Audience:
• Quality Professionals and Management
• Regulatory Affairs Professionals and Management
• R&D Engineers and Management
• Medical Device Executives
Access the printable slides for this presentation by visiting:
www.greenlight.guru/webinar/l...