Posted in Regulatory and Compliance by Nancy Crotti on January 21, 2015
Just in time for the next wave of wearable wellness devices appears ready to roll, FDA has issued guidance statements about wellness products and medtech accessories.
One guidance document defines general wellness products as:
1.Low-risk items such as exercise equipment, audio recordings, video games, and software programs. These must be intended only to help consumers maintain their health and reduce risk of chronic conditions, such as type 2 diabetes, heart disease, or high blood pressure, rather than to cure a particular disease or condition. Uses would include weight management, physical fitness, stress management, mental acuity, self-esteem, and improving sleep management or sexual function.
2. Items intended to promote, track or encourage healthy lifestyles in order to reduce the risk of chronic diseases or conditions, or to help those with such diseases or conditions to live well.
These products could not be invasive, risk harm by using lasers, radiation or implants; or raise novel questions of usability or questions of biocompatibility, the guidance says. It gives examples and even an algorithm to help manufacturers decide if their device qualifies as a wellness product.
FDA’s guidance on accessories is also helpful, but suggests putting the onus on device makers to seek de novo status to prove whether their accessories are unprecedented or similar to existing, approved accessories and thus a surer bet for approval.
That’s an expensive proposition, according to Bradley Merrill Thompson, who recently served on the FDASIA workgroup, according to a report by MobileHealthNews. FDA included many of the group’s suggestions in its draft guidance on wellness devices, the report said.
Device makers may resist pursuing de novo status for their accessories because they would spend significant sums of money in the application process only to have competitors’ similar products ride their coattails to approval, Thompson told MobileHealthNews.
That’s not stopping them from introducing new ones. Displays at the 2015 International Consumer Electronics Show in early January included numerous wearable fitness devices. The website cnet.com gives an overview. More recent stories on FDA regulations and compliance may be found here.
Meanwhile, FDA reiterated its reminder that draft guidance publications are just that: guidance. They are not rules or regulations, but ideas the public may comment on for 90 days from their January 20 release.
Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.
Nancy Crotti is a contributor to Qmed and MPMN.
