Color change is only device modification. Is a new 510k required? - Medical Device Academy

This article explains the process for determining if a color change and other material changes require a new 510k prior to implementing the change.

FDA

Predicate selection guidance proposes controversial additions

New Guidance from FDA: When to Submit a 510(k) for a Change to a

FDA

Medical device regulations, classification & submissions

The state of artificial intelligence-based FDA-approved medical

What Should be Included in a 510k

4 Steps to Master Substantial Equivalence (510k process)

Your Medical Devices Are Getting Smarter. Can the FDA Keep Them Safe? - WSJ

UDI Procedure (SYS-39) and Webinar Bundle

Does Your Device Modification Qualify For A Special 510(k)?