I'm just a comic artist who wears binders and not a legal jargon expert, but this seems SO disingenuous from Trump's FDA. It seems like they're trying to gotcha TomboyX about binders being "medical devices" and TomboyX not having manufactured binders (which are SHAPEWEAR) in compliance with that.
![Our review of your firm’s website revealed statements that these breast binders (example trade names: “Compression Top - Black”, “Racerback Compression Top - Chai”, “V Neck Compression Top - White”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:
Per your firm’s website: “Many individuals who identify as transgender, non-binary, or gender-fluid utilize chest binding as a way to help manage their own dysphoria”
Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “We pay obsessive attention to every design aspect, leaving no detail overlooked so that our community can live and experience a life unbound.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.](https://cdn.bsky.app/img/feed_thumbnail/plain/did:plc:fpycjn6zeurrtubxa3o7i53v/bafkreidlbqnxph4cka6o45blsqv6pg3gb5marifuurz674m5lqqo4upafe)
