The FDA has been busy recently in sending out public notices about bad actors in the medical device space. Though no companies are named specifically here, certain sellers of smartwatches and smart rings apparently claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin using claimed non-invasive techniques, which are extremely dangerous claims to say the least if there is no data to back them up.
I have a feeling we will be hearing names soon of these companies either in terms of FDA warning letters or other press reporting. Blood glucose readings are high stakes data that can definitely result in injury, serious harm or death for those that depend on reliable readings for managing their health. You better believe the FDA statements that “The FDA routinely monitors the medical device market and became aware of unauthorized products being marketed to consumers…The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
Practically speaking, some actions (but not limited to) that FDA can take against such companies that violate medical device rules that are under FDA authority include the Federal Trade Commission (FTC) issuing cease and desist orders (that can carry civil and criminal penalties), FDA issuing direct warnings to companies to cease and desist (which can also carry civil and criminal penalties), as well as FDA authorized seizure of product either in the US or seizure of products as it tries to make entry into US from foreign manufacturers/shippers. People may sometimes wonder if the FDA will actually flex their authority when non-validated products try to enter the US markets with unsubstantiated claims. I would say this is clear sign that FDA will take appropriate actions available under FDA authority, potentially quickly, particularly if there are real threats to health and safety.
