FDA releases guidance on regulation of ‘wellness’ med devices and accessories

The Food and Drug Administration posted two draft guidance documents today saying that it intends to use a light touch when regulating medical devices and accessories that are focused on general wellness.

Such products are those designed to “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.”

Many in the medical tech community have been deeply concerned that an overzealous FDA could stifle desperately-needed innovation in the development of new health technologies. Those people are likely to be happy about today’s news.

“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.

As for medical device accessories, the agency will regulate based on the risks they present when used with their parent devices, and not based on the risks of their parent devices. For example, 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 is less enthusiastic here. “This guidance, in contrast to the wellness guidance, is very difficult to read quickly because the subject is so technical, so even very minor wording issues can have profound impact,” he says. “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.”

The FDA says an accessory device is 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.

You can find the whole guidance on accessories here.