Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
FDA classifies skin patch for hyperhidrosis as class II medical device with special controls, not a cosmetic under MoCRA.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Businesses marketing skin patches for hyperhidrosis as cosmetics or unclassified devices should confirm how it applies to their specific situation before acting. There is a time constraint attached: Immediate for new products; existing products may need compliance within 90 days or face enforcement.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA now regulates these patches as class II medical devices, requiring premarket notification (510(k)) and special controls.
Who it affects
Businesses marketing skin patches for hyperhidrosis as cosmetics or unclassified devices
What you must do
Reclassify product as medical device, submit 510(k), and comply with special controls.
Deadline
Immediate for new products; existing products may need compliance within 90 days or face enforcement.
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