In a stunning policy reversal, FDA announced today (April 1) that it could soon be allowing manufacturers to market their devices under a new EUO label. EUO, which states for "Entertainment Use Only" will allow manufacturers of cutting edge medical devices to market their product directly to the public, provided it carries the new EUO label. Though still in the draft guidance stage, the new label lets companies market their cutting edge product directly to consumers, provided they make it clear that the results, according to a FDA spokesman "in no way represents any useful or clinically relevant information".
According to one anonymous source, the new label is intended to be a response to those that say FDA is more concerned with safety and effectiveness than individual freedoms. "We were sitting around the table debating whether we were truly stifling innovation when someone brought up the alternative labeling" the source said. "We were all like sure, why not, as long as it's clear we don't think the product has any clinical validity, why not?"
One FDA reviewer we spoke to had this to say:
"Look, people have been doing the Special K pinch or taking their own pulse to measure obesity or personal fitness (respectively) for years. Does that mean rulers and fingers should be regulated as medical devices? Of course not! With this new label, people will realize that these results are just for their own personal amusement. If it makes people feel better that they only have a 40% risk of colon cancer, then hey, why not allow that. And if the EUO result turns out to be wrong, well, it's not like we didn't tell you so."
The biotech industry cautiously praised the new label, with most taking a we-will-believe-it-when-we-see-it attitude. But, as one industry spokesman said:
"This is a great day for medical science and for personal freedom. It makes it possible for savy consumers to have early access to technology, and gives them the choice to decide for themselves whether the product is useful or not. This new label opens up markets for products that are barely out of feasibility, so yeah, of course we are excited about being able to provide half-finished products to consumers. I mean heck, the personal electronics industry has done it for years, so why shouldn't we. The feedback we will get from customers will be more valuable than any controlled clinical trial".
The full proposed text of the EUO label is: "For Entertainment Use Only. Not for use in anything even remotely resembling diagnostic purposes." The new EUO draft guidance document is expected later this month, with a public comment period to follow.