The Unit of Caring

Anonymous asked: Unverified claim I coincidentally heard today relevant to your post about 'useless' infomercial products: assistive devices for disabled people get confusingly marketed to general audiences in order to avoid trouble with regulations about selling medical devices, which would come up if the marketing mentioned use for disability.

…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. 

• 28 April 2017
• 284