FDA Guidance on Submitting 510(k) for a Change to an Existing Device – Best Practices to Follow

• By: Staff Editor
• Date: December 01, 2011

The FDA has issued guidance on how to submit 510(k)s for changes to existing devices. This guidance details the types of significant changes that necessitate the need for submitting a 510(k).

This article describes the best practices that medical device manufacturers can follow in order to comply with this guidance.