FDA classifies non-medicated topical treatment for erectile dysfunction as a Class II medical devi
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Table of Contents
The Food and Drug Administration (FDA) has issued a final rule classifying a specific type of non-medicated topical formulation used to treat erectile dysfunction.
Why it matters: This is a regulatory classification change that clarifies how manufacturers must document and prove the safety of these non-medicated topical treatments before they can be sold.
Who it affects
- Manufacturers of non-medicated topical erectile dysfunction treatments
This action was taken by the FDA; readers should consult the Federal Register for the full official text and specific special controls.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document