TomboyX, PBC Warning Letter Details

Summary

TomboyX, PBC was cited for marketing breast binders as medical devices without proper FDA registration and listing. The company's website contained statements indicating the products were intended to treat gender dysphoria and affect body structure or function, which classifies them as medical devices under FDA law. Despite manufacturing these devices, TomboyX failed to register with the FDA or submit required device listing information for fiscal year 2026, violating section 510 of the Federal Food, Drug, and Cosmetic Act.