FDA classifies hyperhidrosis skin patch as Class II medical device
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The Food and Drug Administration has officially classified a type of skin patch used to treat excessive sweating, known medically as hyperhidrosis, into Class II. This classification means the agency believes special controls are enough to ensure the device is safe and effective for patients.
Why it matters: This action reduces the regulatory burden for makers of sweating treatment patches, potentially speeding up access to these devices for patients. It also sets a precedent that allows other manufacturers to follow a less burdensome path to market by using this classification as a reference point for their own products.
Who it affects
- Manufacturers and developers of topical medical patches designed to treat hyperhidrosis.
This information is based on a final order published by the Food and Drug Administration in the Federal Register; readers should consult the original document for full regulatory details.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document