
FDA & Regulatory
INSIGHTS
Expert-reviewed perspectives on FDA-regulated market entry, launch readiness and commercial operations.


Five recurring mistakes when entering the U.S. market across cosmetics, dietary supplements, and medical devices: wrong classification, mistaking registration for approval, skipping restricted-substance checks, no U.S. representative, and copy-pasted labels.
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Assess market, launch, channel, partner and operating readiness for an FDA-regulated product in one connected commercial checklist.
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Are products like derma rollers, LED masks, and microcurrent devices cosmetics or medical devices? We walk through FDA's device and cosmetic definitions, borderline cases, and how to decide.
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