The Food and Drug Administration has decided to put some order into the modern wearables market, having released two draft guidance documents that deal with medical devices and accessories that are focused on general wellness.
These products are described as those that “maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.”
The industry has reacted with joy to FDA’s decision not to stifle innovation. “We said the FDA should not be too conservative here, and should not claim jurisdiction over every product that identifies a disease, and seeks to help people avoid it or live with it, so long as there is widely accepted evidence that a healthy lifestyle can help,” says Bradley Merrill Thompson, a attorney who represents medical device makers at the FDA.
“Indeed, we suggested that the FDA look at food and drug regulation and in particular at the concept of ‘general recognition’ as a basis for not regulating claims where the science is abundantly well established. That’s exactly what the FDA proposes to do,” Thompson says.
When it comes to medical device accessories, FDA will look how they work when used with their parent devices, and not based on the risks of their parent devices.The situation is slightly different when it comes to medical device accessories. Here, the agency will look how accessory works when used with their parent devices, and not based on the risks of their parent devices. So, if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, the FDA would regulate the accessory as a Class I rather than a Class II device.
Thompson says the industry isn’t too happy with this solution, as it can be difficult to read quickly because the subject is so technical, so even very minor wording issues can have profound impact. “I’m also a little less in love with this guidance document, in that it does not go as far as I’d like to see. Basically it doesn’t solve the problem, but instead suggests that the industry solve the problem itself,” he added.
The accessory device is defined as the one that’s intended for use with one or more parent devices, and that is intended to support, supplement, and/or augment the performance of one or more parent devices. The whole guidance on accessories is available from this page.
[Via: VentureBeat]