FDA Encountering Resistance from Whoop in Regard to Blood Pressure Data Tool
The technology world has been abuzz with the recent developments between the Food and Drug Administration (FDA) and fitness tech company, Whoop. The centre of the controversy is Whoop's Blood Pressure Insights (BPI) feature, a component of their latest wearable device, the Whoop MG.
The FDA has classified the BPI as a medical device, requiring regulatory oversight and FDA approval due to its potential to provide numerical blood pressure data that could be used to detect or manage health conditions like hypertension. This classification is in contrast to Whoop's stance that the BPI is intended for wellness purposes only, helping users estimate blood pressure trends to optimise sleep, recovery, and performance.
| Aspect | FDA's Position | Whoop's Position | |-------------------------------|-------------------------------------|-----------------------------------| | Classification | Medical device (requires FDA approval) | Wellness feature (not a medical device) | | Reasoning | Provides numerical blood pressure estimates that could inform medical decisions | Provides daily estimates for wellness optimization | | Regulatory action threat | Civil penalties, injunctions, seizures if non-compliant | Defies FDA warning, seeks dialogue instead |
The FDA has issued a warning letter stating that the BPI operates as an unauthorized medical device and has potential risks if the readings are inaccurate, threatening enforcement actions if Whoop does not comply. However, Whoop refuses to disable the feature and has requested a meeting with the FDA while continuing to offer BPI to consumers.
The Whoop MG is Whoop's latest display-less tracker, and the BPI feature is exclusive to this device. The BPI is labelled as a wellness-focused tool, not a medical tool, by Whoop. The FDA's interest in the BPI stems from the Whoop MG's lack of certification for its blood pressure tracking capabilities.
Despite the FDA's stance, Whoop believes it is not within the FDA's authority to regulate the Blood Pressure Insights feature and does not intend to remove it. The FDA has not authorized the use of Blood Pressure Insights for any purpose, including for the measurement or estimation of a user's blood pressure. The FDA maintains that the BPI does not fall under the general wellness device policy.
The FDA states that Whoop should seek "prompt action" to rectify its lack of appropriate certification for the Blood Pressure Insights feature. The BPI feature provides daily estimates of systolic and diastolic ranges from the wrist, and is available only for Whoop Life plan members, which costs $359 per year.
This controversy has sparked a heated debate about the boundaries of technology in healthcare and the role of regulatory bodies like the FDA in ensuring consumer safety. The FDA's statement comes from a report by Bloomberg published on August 13, 2022. As the situation unfolds, it will be interesting to see how Whoop responds to the FDA's demands and whether the BPI feature will remain a part of the Whoop MG device.
- The FDA's classification of Whoop's Blood Pressure Insights (BPI) as a medical device signals a potential expansion of technology's role in managing health-and-wellness, particularly in medical-conditions like hypertension.
- The integration of smart-home devices and gadgets like the Whoop MG, with features such as the BPI, raises questions about technology's boundaries in the healthcare sector and the necessity for science-backed regulations to ensure health-and-wellness, and smart-home devices' accuracy.
- The ongoing controversy between the FDA and fitness tech company, Whoop, over the regulatory oversight of their Blood Pressure Insights (BPI) underscores the importance of technology in health-and-wellness, and the need for clear guidelines to prevent misuse while promoting safety and user trust.
