The FDA issued its new draft guidance for how it defines a low risk product promoting health management and when that device crosses into the territory of medical devices. The goal is to clarify regulations governing the rapidly growing area of sensors and wearables market on full display at the CES conference this month. It’s particularly interested in clarifying not only products that cross into areas like helping people relax, concentrate and improve self-esteem, but also businesses that are pitching their products for specific conditions.
By the FDA’s reckoning, a general wellness product becomes a medical device when it refers to its use for a specific disease or condition and that application is invasive or goes beyond the general goals of most wearables — to help people monitor their exercise, food consumption and heart rate.
But devices that claim any of the following aren’t general wellness devices according to the draft guidance:
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- the product will treat or diagnose obesity;
- it will treat eating disorders, such as anorexia;
- it helps treat anxiety;
- a computer game that will diagnose or treat autism;
- a product that will treat muscle atrophy or erectile dysfunction;
- a product that will restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.
The draft guidance takes a common sense approach to the issue. But several wearables companies are working with medical research centers to assess their technology for specific conditions. InteraXon for example, makes Muse headbands which are accompanied by an app to help people focus their minds through a set of exercises. It’s generating interest from the likes of Mayo Clinic and Veteran’s Association to apply it to things like PTSD and depression. If and when they come back with positive results it will be interesting to see whether companies like this will be interested in pursuing 510(k) clearance so they can expand their audience to these patient populations.
The regulatory group is seeking public comment on the guidance for the next 90 days.
