Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices.
The guidance document, General Wellness: Policy for Low Risk Devices, explains that FDA's medical device regulator, the Center for Devices and Radiological Health (CDRH), "does not intent to examine low risk general wellness products to determine whether they are devices [under federal law] … or whether they comply with the premarket review and post-market regulatory requirements for devices."
Ordinarily, products classified as medical devices either need to be approved by FDA or need to show that they are highly similar to an existing device (the premarket notification process) or that they comply with establish standards for the production of a device (such as a band-aid).
So what is a "low-risk general wellness" product?
FDA defines them as products solely intended for a general audience (e.g. not marketed at patients with obesity or diabetes) and presenting "a very low risk to users' safety." FDA cites examples including exercise equipment, audio recordings, video games, (some) software programs and devices commonly obtained from retail establishments.
So, for example, if a device makes a claim that it can help you improve your general health, FDA says it does not plan to regulate it. Such devices include ones claiming to help:
- weight management
- physical fitness, including products intended for recreational use
- relaxation or stress management
- mental acuity
- sleep management
- sexual function
However, if a device or an app claimed to treat or diagnose obesity, anorexia, autism, anxiety, erectile dysfunction or any other disease or condition, it would fall afoul of FDA's policy and be regulated as a medical device.
FDA's guidance also goes on to define the term "low risk" further. It explains that a device would not be "low risk" if it is invasive (i.e. penetrates the skin), poses a risk to a user's health (such as increasing exposure to radiation), raises biocompatibility questions (i.e. causes allergic reactions when exposed to the skin) or "raises novel questions about usability."
This latter example was not defined by FDA in its guidance.
General Wellness: Policy for Low Risk Devices