Ixnay on the "lasers" if you don't want your device to face regulatory scrutiny

On Friday, FDA issued a draft guidance aimed at shedding some light on what sort of devices (including apps) the agency considers to be low risk general wellness-oriented ones, and therefore exempt from oversight. There's nothing too shocking in here the broad strokes were telegraphed in a final guidance on mobile medical apps in 2013. The bottom line: FDA has plenty on its plate already, thanks very much, and will focus its regulatory authority only on those devices and apps that can harm their users.
For general wellness products, this means that products including exercise equipment, audio recordings, video games, software programs and other products that are commonly available from retail establishments are off the hook, provided that they:

  1. Don't make reference to specific diseases or conditions, or
  2. Do so only in the context of fuzzy claims that they may help to reduce the risk of certain chronic diseases or conditions, or may help living well with such conditions.

So if your product promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of blood pressure, you're on Easy Street. If, on the other hand, your product simply lowers blood pressure, well, you might want to loop in MLR.
FDA also defines low risk devices to preclude:

  1. Those that are invasive, meaning that they penetrate or pierce the skin or mucous membranes;
  2. Those involving an intervention or technology that may pose a risk to a user's safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants;
  3. Those raising novel questions of usability, or
  4. Questions of biocompatibility?

So sunlamps? Totally regulated (due to risk of skin cancer, among other things). Laser skin treatments? Regulated. Implants? Regulated with extreme prejudice. But the makers of health and wellness apps, for the most part, have nothing to worry about.

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