In April of 2019, the FDA issued a warning to the public against unapproved devices that claim to assess, diagnose, or manage a head injury. They specifically mentioned tools like apps that are marketed to coaches or parents for use during sporting events. The fact that unlicensed medical devices and software have slipped through the cracks is a terrifying prospect.
As a result, It points to a larger issue in the medical device industry. There is a lack of control or regulation that leads to counterfeit hardware and software entering the market. Given that these devices diagnose diseases and provide treatment, false or non-functional medical devices could mean the difference between life or death. While the FDA should, theoretically, protect us from these threats, they cannot do it alone. It’s time we take a stand against counterfeit medical devices.