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.

theunitofcaring:

…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 the fee to submit a 510k, the form to ask for permission to market any kind of medical device (including toothbrushes), is $2300 for a small business ($4690 if you don’t count as small). And that’s just to apply, you still might get rejected. And I can’t figure out under which conditions all the other fees on that table apply but some of them usually apply as well (not the $230,000 fee, thankfully).

So, yeah, unless you’re a big established company for who that’s nothing and the cost of the lawyers is no big deal, it’s way safer not to admit that your product is for disabled people or to advertise in a way that suggests it is a solution to a specific condition. And so we get generically incompetent infomercial people. 

• 28 April 2017
• 284