The manufacturer of the WHOOP fitness band offers, within a special subscription, the option of displaying an estimate of the diastolic and systolic values. According to the FDA, the two individual values amount to a blood pressure reading and are therefore suitable for diagnosing hypertension or hypotension. In a warning, the FDA therefore described the product as misbranded and adulterated.
WHOOP, however, insists on its status as a wellness feature. Together with sleep and recovery, it argues, blood pressure provides information about general performance. The function is clearly labelled as non-medical. The FDA warning is currently no reason to withdraw the function from the market.
For context: while the MDR primarily uses the manufacturer’s intended purpose as the basis for deciding whether a product is a medical device in the EU, the FDA argues differently here. Reporting blood pressure is “inherently associated” with the diagnosis of hypotension and hypertension. That, it argues, is what gives rise to the medical function.
Read the Handelsblatt article on this:
Whoops Wearable: CEO widerspricht FDA: Blutdruck-Feature bleibt