Early to Bed, Inc. Warning Letter Details

Summary

Early to Bed, Inc. was cited for distributing breast binders (including the GenderBender line) as medical devices without proper FDA registration and listing. The company failed to register its manufacturing establishment and list its devices as required under section 510 of the Federal Food, Drug, and Cosmetic Act, resulting in misbranded devices under section 502(o). The FDA determined the binders qualify as medical devices because manufacturers claimed they were intended to reduce post-surgical swelling and affect bodily structure or function. The company was warned that failure to promptly address these violations could result in seizure, injunction, or other enforcement actions.