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FDA Guidance on External Penile Rigidity Devices

The FDA provides guidance on external penile rigidity devices, including design safeguards, labeling, and limits on intended uses to reduce risks.

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Jan 11, 2026

What safety features and usage limits does the FDA recommend for external penile rigidity devices, and how do popular models measure up?

The FDA’s Class II special controls guidance for external penile rigidity devices emphasizes design safeguards (notably a manual quick‑release for vacuum pumps), clear labeling and contraindications, ...