Health and medical products attorneys are alerting makers of wearable technology that they might be facing a period of escalated surveillance by the US Food and Drug Administration (FDA), particularly around the question of whether their products and related software functions should be regulated as medical devices.
The agency sent a warning letter to WHOOP Inc. in July regarding a function the Boston-based company calls Blood Pressure Insights, or BPI. In its letter the agency claims BPI is a device because it “intends for … users to measure or estimate their blood pressure.”
The letter goes on to say WHOOP’s website described BPI as providing “daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being,” and included a claim that WHOOP is “delivering medical-grade health and performance insights.”
Before the letter was sent to WHOOP, officials there had been in contact with the agency over the matter. The company told the FDA at the time that BPI is a “wellness feature” and not a device because it’s not intended to diagnose, cure, mitigate, treat, or prevent disease or other conditions.
“The warning letter is specific to WHOOP, but insofar as we can make some assumptions based off the warning letter, we assume that there could be an increased oversight over wearables.” – Victoria Hawekotte
But the FDA disagreed, noting in its letter that BPI “is intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease,” which makes it a medical device.
After receiving the warning letter, WHOOP “respectfully disagreed” in an online post and maintained that BPI is a “wellness feature, not a medical device.”
“FDA’s main rationale for [writing the warning letter] is that a blood pressure estimate … is inherently associated with diagnosis of hypo- or hypertension,” said Victoria Hawekotte, whose focus is health law as an Associate Attorney in the Philadelphia office of Duane Morris LLP.
In its letter to WHOOP, the FDA also referred to its 2019 final guidance document on low-risk general wellness devices, which says the agency won’t enforce its authority over such products.
But the letter pointed out that “the Blood Pressure Insights feature is actually not low risk because providing a blood pressure estimate is inherently a high-risk process, partially because of the prevalence of high blood pressure in the US and the risk that a false-negative could lead a user to forego medical treatment or not see the doctor because they’re under the impression that they don’t have hypertension, which increases your risk of stroke, among other things,” Hawekotte said.
The FDA also said in its letter that BPI is a higher-risk product because the agency already actively regulates and has cleared devices that are intended to measure and estimate blood pressure.
“It is absolutely essential that you know whether or not your product is a medical device.” – Frederick Ball
“The warning letter is specific to WHOOP, but insofar as we can make some assumptions based off the warning letter, we assume that there could be an increased oversight over wearables [and] maybe a departure from [the FDA’s 2019] guidance,” Hawekotte said. “But so far, we haven’t observed that happening. We haven’t seen an influx of warning letters that are related to general wellness products classifying them as devices, but it’s still important to monitor FDA movements in this area.”
She added: “If you’re a manufacturer of a product that has a function that is inherently associated with diagnosis, such as a blood pressure monitor and estimation, then this is important to keep apprised of.”
Frederick Ball, a Partner in the Boston office of Duane Morris, noted that the FDA is not only concerned about the intended use of a product, but its actual use, as well.
“You could see that in the WHOOP warning letter,” he said. “It is absolutely essential that you know whether or not your product is a medical device. If it is, you’re subject to FDA regulation, and if you market it without … marketing clearance, that’s a violation of the law, and the Food, Drug, and Cosmetic Act has both civil and criminal penalties. Unless somebody gets harmed by your device, it’s unlikely [the FDA] would come after you criminally, but the civil penalties can be pretty prohibitive.”
Comments from Ball and Hawekotte came during the recent Duane Morris webinar, “Update on FDA Regulation on Wearables.”