FDA "seal of approval" in device labeling may be addressed in guidance -- device center's Sheehan.
This article was originally published in The Gray Sheet
Executive Summary
FDA "SEAL OF APPROVAL" GUIDANCE UNDER CONSIDERATION to clarify for manufacturers the different types of labeling statements they can make about FDA approval for different types of devices. The guidance would expand on a provision of the FDA Modernization Act that repeals a prohibition on making FDA approval claims in product labeling.