…that is super interesting. I looked into it, and it seems reasonably legit: the FDA rules on marketing medical devices (defined expansively enough to include manual toothbrushes) require for example that before marketing the device you prove it is substantially equivalent to an existing device, or qualifies for an exemption (or if there’s no existing device you prepare and submit a De Novo request but wow lotsa paperwork), and comply and demonstrate compliance with a bunch of regulatory standards.
That’s easily hours and hours of lawyer time, and it makes sense that a small business making plastic sleeves that help you put on your shoes, or self-stabilizing spoons that are obviously meant for people with Parkinsons, would decide to avoid counting as a medical device at all costs.
Also worth noting that, thanks to the curb cut effect, non-disabled people buying disability products is very good for the disabled people who need them. So, even if marketing to a general audience is done for legal reasons, general audiences should very much not be shamed for buying these products. Doing so is actively good for the people who need them.
Tags:
#ableism cw #interesting
Brinens and Things 