A Canadian brewery became tangled up in medical device license law after its latest marketing stunt
Good Robot Brewing has had its logo printed on matchbooks and rolling papers – and recently decided to print onto condoms in its latest marketing drive.
Little did the firm know, it had unwittingly wandered into the thorny medical device arena. In an interview published on local Canadian news site Herald News, Good Robot co-founder Joshua Counsil explained that the group had been planning to hold a Valentine’s Day event to promote safe sex.
The company only ordered 100 of the promotional condoms, and yet according to Joshua, government department Health Canada was quickly on the case with notice of two regulatory violations.
Counsil explained: “Unfortunately, we got this notification this week from Health Canada which mentioned two regulations that we were apparently violating. It had something to do with importing a medical device and distributing a medical device without a licence to do so.
“I didn’t know condoms were considered a medical device, considering you can get them over the counter anywhere.”
According to the FDA: “Male condoms are classified as Class II devices under 21 CFR §884.5300 and §884.5310 (Condom with spermicidal lubricant) and are not exempted from 510(k) requirements, therefore, a 510(k) premarket notification must be cleared by order of FDA before a new male condom, or one that has been significantly changed or modified, is introduced into interstate commerce.”
Counsil added: “There’s so much that happens here in the run of a day that we never fully think through all our ideas, which is part of the reason we get in trouble quite a bit.”
Medical device regulation is a complex business – so stay safe folks.