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.

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FDA

Substantial Equivalence - an overview

FDA

FDA Guidance on 510(k) for Changes to Existing Devices

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

FDA

What Should be Included in a 510k

Substantial Equivalence - an overview

Does My Modified Medical Device Require a New 510(k)?

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