Hands-On Workshop on Preparing and Maintaining 510(k) Submissions
The 510(k) process is the most used route to market for medical devices in the U.S., yet it remainsone of the greatest challenges for manufacturers. In this intensive hands-on workshop, you will learn how to independently prepare, structure, and tailor a 510(k) submission to meet FDA requirements.
You will work your way through the process of building a complete 510(k) dossier step by step: from preparation and identification of the appropriate predicate device to the practical use of forms and templates. You will also learn how to evaluate and document changes to devices that have already been cleared and when a new 510(k) is required.
This module is designed for anyone who already has a basic understanding of the subject and now wishes to deepen their knowledge specifically in the creation, maintenance, and updating of 510(k) submissions.
- Content
- Creating 510(k) content yourself
- Organization, structure, and contents of a complete 510(k) submission (e.g., Device Description, Predicate Comparison, Performance Testing, Labeling)
- Forms and Templates
- Overview of required documents and their proper use, including eSTAR and accompanying attachments
- Changes to 510(k)-cleared Devices
- Evaluation of changes, decision trees (“When to Submit”), documentation, and communication with the FDA
- Your Benefits
-
You’ll be able to independently prepare and structure a complete 510(k) submission.
-
You’ll know which forms and templates are required and how to fill them out correctly.
-
You’ll learn how to properly evaluate changes to existing products and classify them from a regulatory perspective.
-
You’ll receive practical tips to improve the efficiency and quality of your submissions.
-
You will deepen your understanding of the FDA’s expectations during the review process.
-
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
-
Regulatory Affairs Managers and Specialists
-
Staff in the areas of regulatory affairs, development, and quality assurance
-
Manufacturers and authorized representatives of medical devices
-
Service providers and consultants in the field of U.S. regulatory affairs
-
