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.

Understanding the New FDA Guidance on Changes to a 510(k)

Labels for Medical Devices

How FDA Regulates Artificial Intelligence in Medical Products

What is new in the IEC 62366-1 AMD1:2020? - Medical Device HQ

The Top 10 Most-Cited Clauses In FDA FY2021 Medical Device Inspections

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25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

Health Canada Guidance on Determining Medical Device Application

FDA on Software Changes: Additional Factors

Predicate selection guidance proposes controversial additions

FDA

US FDA Pre-Market Notification - 510(k)