Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence

Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S. market access. Yet the process can be complex, with evolving FDA requirements, technical standards, and regulatory nuances that can delay approvals if not addressed properly.

Our comprehensive FDA 510(k) checklist gives you the tools and guidance you need to ensure your submission is complete, compliant, and positioned for timely review.

Why Download This Checklist?

Inside, you’ll find practical, actionable insights that go beyond a simple checklist:

• Understand the 510(k) pathway – Confirm if 510(k), De Novo, or PMA is the correct route for your device.
• Organize your submission – Administrative forms, device descriptions, labeling, testing, and more.
• Avoid FDA delays – Learn the top reasons for Additional Information (AI) requests and how to prevent them.
• Strategic tips from experts – Predicate device selection, risk management alignment, and eSTAR best practices.
• Prepare for interactive review – Proactive steps to respond quickly to FDA queries.

As the world’s leading regulatory consultancy, ProPharma partners with medical device manufacturers of all sizes to successfully navigate FDA 510(k) submissions. Our team of experts provides end-to-end support—from gap assessments and testing strategies to submission preparation and FDA interactions—ensuring your device is positioned for clearance.

Download your copy of our 510(k) checklist and take the first step toward a smoother, more successful submission.