FDA will pull back even further on scrutinizing the worlds of wearable devices, consumer-focused health apps, and even some clinical decision support (CDS) tools used by healthcare providers.
New guidance issued this week excludes certain “low risk” wellness products from being defined as devices subject to FDA oversight.
The exceptions now include devices and apps “intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition,” the FDA says.
Products no longer subject to the rules around medical devices may include wearable devices and smartphone apps that provide biometric information to users and analyze that information to offer insights about a person's wellness – as long as the manufacturer doesn’t make any claims about the product's functionality that imply the product's use in a medical or clinical context.
The FDA also published concurrent guidance targeting CDS tools, which similarly removes certain platforms and solutions from the pool of regulated devices.
In short, the majority of tools that aggregate and analyze non-biological data and present the resulting clinical insights as options instead of answers are no longer subject to the existing regulatory framework.
The potential problem, of course, is that every single element of the patient's data has to be perfect in order for these algorithms to work well enough to guide decision-making – and there's no question that patient data is laughably far from being current, complete, accurate, and trustworthy.
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