Devices

FDA Warns Firm Marketing Blood Pressure Estimator

FDA says Whoop, Inc., Boston, MA, is marketing its Blood Pressure Insights (BPI) medical device without agency approval and despite agency assertions that Blood Pressure Insights is legally considered to be a medical device that requires premarket approval. A 7/14 Warning Letter says the firm’s Web site indicates that BPI provides daily blood pressure estimations.

The letter says the device is adulterated because there is no approved PMA or IDE in effect for it. It is misbranded, FDA says, because the company did not notify the agency of its intent to introduce BPI into commercial distribution.

“FDA has not authorized BPI for any use, including for the measurement or estimation of a user’s blood pressure,” the letter declares.

The letter discusses two meetings the firm’s officials had with CDRH to discuss BPI and explain why the company did not consider it to be subject to FDA authority.

After giving FDA’s reasoning in applying the law and regulations to BPI, the letter says, “At the conclusion of your firm’s calls with FDA, your firm indicated its intention to continue marketing BPI without appropriate FDA authorization despite FDA’s repeated assertions that BPI is a medical device and therefore requires FDA authorization to be legally marketed.”

The letter instructs Whoop to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.

Meanwhile, the company is pushing back against FDA’s letter, contending that the agency is overstepping its authority and restricting access to valuable health data. Whoop CEO Will Ahmed has stated the company will fight FDA’s position, arguing that Blood Pressure Insights is a wellness feature, similar to other trackers that monitor heart rate and respiratory rate. The dispute highlights the ongoing challenge of classifying fitness trackers and their features within the evolving landscape of health technology. Interestingly though, Whoop has previously received FDA clearance for its ECG feature, suggesting that the company is not opposed to device regulation but believing that Blood Pressure Insights falls under a different category.

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