FDA labels blood pressure feature as a medical device, but Whoop remains unyielding in its stance
The Food and Drug Administration (FDA) has issued a warning letter to fitness technology company Whoop, raising questions about the boundaries between wellness and medical devices in the wearables industry. The warning letter centres around Whoop's Blood Pressure Insights (BPI) feature, which is distinctly different from medical blood pressure monitoring tools [1].
The FDA has classified the BPI feature as an unapproved medical device, as it estimates blood pressure—a function the FDA considers medical in nature [2][3]. Whoop disagrees with this classification, asserting that BPI is a wellness feature, not a medical device, and thus should not fall under FDA regulation [1][4][5].
Despite this, the FDA warns that inaccurate blood pressure readings could pose health risks, indicating a regulatory concern about patient safety arising from the blurred lines between wellness and medical uses [2][5]. Whoop maintains that BPI is intended for general wellness and not for replacing clinical-grade monitors or influencing treatment decisions [1].
The BPI feature, introduced with Whoop 5.0 and Whoop MG, provides users with estimates of systolic and diastolic blood pressure. Another feature, Lifespan, is now available for Whoop 4.0 users [6]. Despite the FDA's warning, the Blood Pressure Insights feature remains live on the platform.
Brands like Apple, Samsung, and Garmin are also blurring the line between wellness and clinical-grade monitoring. As health tracking becomes more advanced, the lines between coaching, diagnosing, and treating continue to shift [7]. Regulators are watching closely as these lines blur, with the FDA arguing that Whoop's Blood Pressure Insights could influence diagnosis or treatment [8].
However, Whoop emphasizes that the tool is intended to provide wellness insights rather than diagnose or manage health conditions. Users should treat the Blood Pressure Insights as general trends rather than precise readings [9]. The Blood Pressure Insights interface looks and feels like it's giving a blood pressure reading, but it's important to remember that it's a wellness feature and not a medical device.
The FDA's warning to Whoop signifies increasing scrutiny on smartwatch health tech, as the lines between wellness and medical devices continue to blur. This situation highlights the need for clearer guidelines and regulations in the quickly evolving world of wearable technology.
The FDA's warning to Whoop highlights the necessity for clearer guidelines and regulations in the wearables industry, as features like the Blood Pressure Insights considered wellness features by Whoop, represent a blurred line between health-and-wellness and medical-conditions. Technology advancements in health tracking prompt concerns about patient safety and the potential influence of general-news such as Whoop's BPI on medical-decisions.
