Categories: MediaRegulation

FDA highlights differences between cosmetic and medical devices By Simon Pitman

COSMETICS DESIGN USA – Breaking News on Cosmetics Formulation & Packaging in North America
By Simon Pitman+, 11-Jun-2015


The US FDA has issued a warning notice primarily aimed at cosmetic device manufacturers and distributors to
highlight the differences in market claims and clearance when compared to medical devices.
The FDA says it is primarily targeting cosmetics devices for regrowing hair, weight reduction, spider vein removal and dermabrasion, as well as injectable fillers, stating that there should always be clearly defined definitions for these products that should not use the same descriptions as medical devices.
The body warns that a number of devices being marketed in the US have crossed the barrier because, although they are marketed purely for cosmetics purposes and as cosmetics, any intention to diagnose or treat a medical condition or affect the structure or function of the body, makes them medical devices… read more and follow the link

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