The Whoop Saga and how not to be a credible wellness/medical company.
July 2025 , Sam Moreland
In the medical space over the past few weeks, the FDAs open letter about Whoops non-compliance has drawn 2 very distinct camps:
The FDA is just a huge Goliath trying to beat up a little billion dollar company David (Whoop).
Whoop is an irresponsible “break it till you make it” marketing first company that doesn't care about being truthful or accurate to consumers or the regulators.
Now with anything there is a continuum but I am mainly in the camp of Whoop being massively irresponsible on this issue (not every issue). I have written extensively before about the problems with wellness devices claiming medical competency to market their products. It is bad for the patient/consumer and it is bad for the reputation of start-up medical companies.
I will be reacting to the pro-Whoop arguments as it's a great place to weed out the nuance and understand the really important points in regulation and patient safety.
Background
Whoop is a wellness/wearables company who make a smart wrist band that uses sensors to take in “biometric” information about the user. Previously they have been focusing on the fitness market where they give out metrics around recovery sleep etc. Nothing that can actually be used to medically treat patients (or easily be validated for efficacy). Recently however they have been trying to incorporate more medical features into their product.
On the 14th July, the FDA sent Whoop a warning letter related to the marketing of their new BPI (Blood Pressure Indicator) feature. This is a novel feature created by Whoop and is being contrasted with BP (Blood Pressure). The BPI feature according to whoop:
“is a wellness feature. It gives members a daily estimate of their blood pressure range, based on passive, overnight data, to help optimize sleep, recovery, and performance. It’s accurate and non-invasive.”
Here wellness means its not used for medical purposes therefore does not need to get validated/proved for safety.
But the FDA disagrees and so do I (and a lot of medical device professionals). This is where the issues began…
What the FDA said…
You can skip this if you don’t want to read as I’ll give a tl;dr in the next section. This is all taken from the FDAs letter you can read here.
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“Based on our review of these materials, your firm offers BPI to users and intends for those users to measure or estimate their blood pressure. Your website describes the product 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." Your website further lists BPI as an example of how WHOOP is "delivering medical-grade health & performance insights." The associated article clarifies that "the impact of blood pressure on sleep, recovery, and performance are not well understood or widely studied…
FDA has not authorized BPI for any use, including for the measurement or estimation of a user's blood pressure."
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“Your firm sent a letter dated June 2, 2025, to describe the purpose of the BPI feature, how it works, and why you believe it is not a medical device subject to FDA regulatory authority. In these calls and this letter, your firm represented that it was indeed marketing BPI without any marketing authorization from FDA and that when used, it would provide a user with a daily estimation of their blood pressure. Your firm indicated that you believe that BPI is not a device under section 201(h) of the Act because you believe it is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”
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“Based on FDA's evaluation of BPI's intended use, the product 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. This conclusion is bolstered by both your firm's statements about BPI (e.g., "Higher blood pressure may be an indicator of poor sleep." [emphasis added]) and BPI's design, which outputs a blood pressure measurement to users and provides the reading on a gauge that uses green, yellow, and orange color-coding to indicate a target blood pressure range.”
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“Although BPI provides a daily blood pressure range and midpoint measurement instead of a real-time reading, that is not sufficient to distinguish the product's intended use from other blood pressure measurement devices, because a blood pressure range or midpoint estimation, like a real-time reading, is inherently associated with the diagnosis of hypo- and hypertension…
Even accounting for BPI's disclaimers, they do not change this conclusion, because they are insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation that is inherently associated with the diagnosis of a disease or condition.”
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“Although traditionally blood pressure has been checked in a healthcare setting, ambulatory blood pressure checks are now in the American Heart Association (AHA) guidelines”
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The letter goes on in great depth and detail as to the rationale of the FDA which in my opinion is pretty robust.
What this means and why this matters
In short, Whoop are claiming they don’t measure BP because its BPI (totally different), a new metric they just made. Now BP measurement devices are regulated by most countries because of the use in diagnosis and treatment of serious conditions. As such BP devices must pass strict safety and validation requirements. Whoop are claiming all the functionalities of a BP measurement, but because they put a disclaimer on the product and its call it “wellness”, that it's not used for diagnosis and therefore it doesn’t need regulation (because everyone always reads the GDPR consent or the terms and conditions).
The FDA points out that BP is not a wellness feature and is used to diagnose serious conditions, and as such should be medically regulated. They say that if BPI claims the diagnostic applicability of BP then it should be regulated as BP. I think if you say “BPI is intended to identify higher blood pressure" but then add a disclaimer saying it's not diagnostic, it is clearly misleading.
Even worse, the marketing for Whoop claims that they are “delivering medical-grade health & performance insights” and even call the product Whoop Medical Grade (MG). Now Whoop has clearance for their ECG functionality but not for BPI or any other wellness metrics. They are deliberately using marketing to conflate the whole product as medical grade when they are just cleared for a small subset of features.
This is the pernicious encroachment of non-medical devices claiming to help sick people manage their conditions. The FDA is clearly doing this not just to send a message to Whoop, but the whole industry. Whoop may feel hard done by as many companies before them have done the same things, but this had to happen!
The misunderstandings of medical regulation
The big misinterpretation of the regulatory pathway is it is just there to make sure a device doesn't explode or meets the validation criteria (which it does do). Regulation is there to make sure the company works in a medically competent way so that when they do design/development/post market surveillance, that they do it in a way to minimise patient risk, it is a company process not a check box.
If you create a medical product that is accurate for BP, but you have no documentation, no risk analysis, no process to triage complaints or root cause them, then you cannot market it as a medical product. The process matters! You can't just be good at one part of the process, you need to demonstrate that you take all of it seriously because the different parts of the process are not independent. They work together to make sure the patient or consumer is safe.
Wills (CEO) and Whoops response to this shows that at least from the top they do not have these qualities because they can’t even accept the minor modifications the FDA are asking for. Just make it clear to the end user that it's not measuring BP. It is such a tiny thing to change on their end, it's like they are trying to drum up controversy. The fact they have a disclaimer is not a defence.
You may think in this situation the outcome is minimal as most people would know the difference. But in medical device design you don’t design for the average use case, you design for the edge cases because performance in those situations is where it actually matters. Medical regulation is actually pretty lightweight to what it could be and is there because the outputs of it make the company prove that they have thought about and controlled for edge case performance. In good companies this just naturally falls out.
The arguments for Team Whoop and their counterpoints
As I mentioned in the intro, things like this are not just clear cut. Blythe Karow has written an excellent series of posts where she outlines why the FDA might be wrong. But I have to disagree with most of what she thinks. I’m going to go through the arguments and why I think they’re wrong. I will quote liberally from her piece but please read it for the full perspective.
1 - This is not a clear cut case and the FDA is too complicated
“This isn't your typical Silicon Valley "move fast and break regulations" story. WHOOP actually has a track record of working within FDA's framework when they deemed it appropriate, spending years getting their ECG feature cleared. What went wrong here reveals something systemic about how the wellness device pathway actually works in practice.”
“I think what's missing is a light-touch pre-review pathway where companies can submit wellness review requests to review their marketing claims and make sure they aren't overstepping the bounds before significant market investment.”
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It's a good point, but what this really makes me think is because Whoop have previously cleared things past the FDA, why not this? Is it because it's inaccurate? Combined with the social media outrage I would definitely class it as a typical “silicon valley” story. Change the narrative rather than address the shortcomings with your product.
There already is a light touch pathway, it's called the Q-sub. You send some questions to the FDA regarding the development of your devices and understand what the regulatory scope is and validation criteria. It takes 2 months to get a response and you meet with them in person to discuss it and iron out any misunderstandings. Whoop already had several meetings with the FDA and decided to ignore the minor changes the FDA asked for.
2 - Other types of device provide medically diagnostic information and are not regulated
“The real conversation shouldn't be whether all BP measurements are inherently diagnostic (that's a stretch), but rather how FDA's wellness guidelines should be revised to allow biomarker collection while providing clear guidance on handling detected extremes and establishing validation requirements for companies operating in this space…
By FDA's most obvious position, bathroom scales would be medical devices because weight is "inherently associated" with obesity diagnosis and we all know obesity increases the risk of type 2 diabetes, heart disease, stroke, and at least 13 types of cancer, plus causes an estimated 3.7 million…”
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This is a very valid criticism, but I think it is a problem with practical implementation not with double standards. Because the FDA draws a line somewhere not perfect doesn’t mean they shouldn’t draw a line (not that she is arguing that). If any health metric would change the course of medical treatment for a patient, then it should be considered diagnostic. The weight scale example is interesting, maybe because body fat, which is the main problem, is highly visible as an indicator whereas BP, ECG etc are not. Maybe its just a legacy from some decision decades ago. It's not a perfect response I grant you. But I would also suggest that people probably have been given false readings from scales that may have led to incorrect assumptions about their health. Weight is used in risk scores for patients.
Lack of clarity from the FDA on when a wellness product becomes a medical product is also valid. Maybe a giant list of words that you cannot claim about; the standards are there but they are quite opaque taken as a whole. But I still think the wellness/medical device guidance on this issue is clear and they still have the Q-sub pathway to clear up any misunderstandings.
3 - Whoops language and intent is clear.
“the FDA found specific language from WHOOP that crossed the line into diagnostic territory. They quoted WHOOP saying "Higher blood pressure may be an indicator of poor sleep" and noted that WHOOP's materials indicated BPI was intended to identify "higher blood pressure."
I would actually argue that the distinction between "higher" and "high" blood pressure matters here. "Higher" describes a relative change or trend within an individual's personal baseline and I believe this should be considered acceptable for a wellness device. However "high blood pressure" does suggest comparison to a clinical diagnostic threshold. The problem is that WHOOP appears to have consistently used "higher" (relative language), but the FDA transformed this into "high blood pressure" in their own interpretation, writing that "BPI and its labeling would indicate to a user that her poor sleep may be caused by high blood pressure identified by the device." “
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I agree that language matters but in a different way. The lack of differentiation between “higher” and “high” is incredibly important because it's not just the legal definition, it's how the lay person would interpret it. The same with “BP” and “BPI”. These terms are marketed very close to medically important words, deliberately, because they are conflating the marketing of wellness with a medical device. If they called it something completely different like “Body Stress Level” then it's quite a clear distinction to the lay person. This is the loophole the companies use to confuse consumers about products that are correct for them to use in the monitoring of their diseases.
4 - People use other non-regulated biometrics for their health.
“The FDA cited "evidence of individuals using BPI to monitor their hypertension" as a sign that WHOOP had overstepped the line. I'm concerned about the FDA's argument here for two reasons.
First, using anecdotal misuse by some users to justify broad regulatory classification, especially when they provided no details about scale, frequency, or how this evidence was collected, sets a concerning precedent. Second, people use fitness trackers for wellness purposes all the time and those wellness issues often connect to more serious health conditions. Sleep quality can impact anxiety or cognitive health, getting your 10,000 steps can help with overall cardiovascular wellness, and using heart rate data can help you understand stress levels…
While we want to be careful of products purposefully trying to skirt a medical device pathway, some off-label use is probably acceptable when it leads people to healthier lifestyles that could improve more serious conditions.”
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Firstly anecdotal misuse without data. Foreseeable misuse is part of the ISO 14971 risk framework which not only covers the design of the device but the instructions for use. 14971 is a part of the regulatory framework that shows how the design of the product (including labeling/marketing) has been done to minimise the harm to the patient as much as possible. This includes how they have designed it against foreseeable misuse i.e. obvious ways in which a patient or medical professional could use it to harm the patient (including misunderstanding the readings).
It's a bit of a catch 22, because if they were a medical device they wouldn’t be able to claim BPI because there is no need for validation, but because they think they are not a medical device they don't? I think the spirit of 14971 should still be taken into account with wellness. The naming of this easily causes foreseeable misuse, I think is pretty easy to see.
At the end of the day you have no idea what will happen to the information given by the product to the consumer/patient, they will not use it the way you think they will. You need to minimise the likelihood of harm occurring.
Secondly, co-morbidities and diagnostics are not the same thing. As with everything in medicine it's a combination of factors weighed at different levels of validity. While lack of sleep can be an indicator, sleep quality as a measurement inherently does not have a body of evidence behind it to suggest direct treatment changes, and when it does it should be regulated. BP has a huge body of evidence behind it with suggested direct treatment changes.
Lastly it cannot be off-label use because it was never on label. There is 0 credible validation for this product. Happy to be proven wrong if they release the validation studies (or someones links them to me), but just saying you have done validation studies does not mean they actually validate the product.
5 - The way Whoop displays BPI measurements should not be regulated.
“The FDA also objected to WHOOP's green/yellow/orange interface, claiming these color-coded readings imply medical interpretation. This seems ridiculous to me. Every kid watching Sesame Street understands the implications of red/yellow/green, and it's not inherently a medical thing.
Every fitness wearable uses identical color-coding schemes: Garmin shows heart rate zones in green/yellow/red, Apple Watch displays activity rings with the same traffic-light logic, Fitbit shows sleep scores with color indicators, Oura rings display readiness ratings using similar visual cues…
If color-coding implies medical interpretation, are we going to start requiring submissions from all the manufacturers of street lights?”
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The traffic light argument is a bit misleading. Context matters, red light in a car means stop, red light in a hospital could mean SVT. Heart rate zones are based on validated pulse pressure measurements. Readiness / activity / sleep scores have no diagnostic or treatment implications.
Colour coding, sounds, icons are covered in many medical standards because they are a shorthand for diagnostic interpretation. A doctor using 2 different devices should be able to transfer from one to the other and understand that the indicators are similar. It's a fast pattern recognition that doctors and nurses are trained/learn to do. Now this is more important for use by a medical professional because they are there to have a quick response to a situation. While it may not seem important, colour coding would create misinterpretation for the lay person.
Probably worse for Whoop, it shows the FDA another non-compliance that they are doing. As I mentioned before, it's about the whole company being serious and the FDA is looking for non-compliance. Once is a mistake, twice might be lazy, three times you may just be trying to dodge regulation (three strikes is not FDA policy as far as I’m aware).
(This glosses over the issues with colour coding or sounds being useful, such as alarm fatigue).
6 - If you collect medical grade data you should be able to call yourself medical grade.
“Their website described Blood Pressure Insights as an example of them delivering "medical-grade health & performance insights."
That single adjective, "medical-grade," was regulatory poison. In FDA's world, this term implies clinical accuracy, validation standards, and regulatory approval whether intended or not…
To be clear, you can have a wellness device that collects medical-grade data, and this is preferred because then algorithms are using good, clean data to build their insights. The problem was with WHOOP using the term in reference to them providing blood pressure insights that were medical grade. This implies providing a medical device diagnostic level of BP measurement.”
“After review of the FDA letter, it seems the medical-grade implication is the real sticking point. If WHOOP had gone back and proposed to make those changes, they might not be in this situation now.”
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Now Blythe isn’t directly making the argument that Whoop should be fine to call themselves “medical grade”. In fact she says this is the sticking point that they probably should have changed. But it does highlight an important misunderstanding that people can have, that because they collect “medical grade data” that inherently makes them a medical grade product.
“Medical grade” is not just about the quality of the sensors, it's about the applicability to the intended use of the product. A heart rate monitor could be created to accurately measure heart rate between 60 - 100 bpm, but it wouldn’t be “medical grade“ because it needs to measure between 30-240 bpm to cover any the needed use population (60601-2-47). Regulatory standards for SpO2 make you test on different colour skin tones because that affects the readings. Whoop cannot just subsection and say something along the lines of “our intended use population are all fit therefore it doesn't need to be regulated” (this is my assumption, I’ve not seen the intended use).
Medical grade is one of the big points, it conflates the whole product as being medically competent, not just the cleared features. But if it wasn’t there the issues with BPI and BP would still exist…
In conclusion…
If you’ve made it this far, well done! I appreciate it. While it may seem murky on the surface and that BPI may just be an innocuous claim, there are actually far more serious things here.
The conflation of non-medical products with medical products. If you are not a medical product you don’t have to demonstrate patient safety, which requires time, money and knowledge. Wellness companies will try everything to not go down it for the sake of marketing. This leads to misleading patients that may start using the product for managing their conditions. Whoop clearly knows the difference and chooses to ignore it. They rather grandstand on social media rather than make minor modifications to their marketing. This is the actions of a non-serious, non-compliant medical company.
Regulation is there to make sure the company works in a medically competent way, not just say your BP monitor is accurate. You need to show you comply within every area that relates to patient safety. This is not just validating accuracy, it's how you communicate with the patient, deal with complaints, design the product to be inherently safe etc. The FDA will regulate you on being a medically competent company.
There is a distinction between wellness metrics like “sleep quality” and diagnostic measurements like BP. Sleep quality has no diagnostic indications, but could be taken as a risk factor, whereas BP has direct diagnostic and treatment implications.
Now there are degrees and its not just a binary, but the murky ground in the middle should not default to you being able to market it. You should listen to what the FDA say and comply with it. What Whoop did was the opposite and claim they are the victim. There are valid reasons for regulation and to be honest, getting passed the FDA is fairly trivial if you know what you are doing. But you can’t treat it like a check box exercise. Its a relationship with the regulator to prove your company is competent enough to make a medical device. Saying you are not a medical device and arguing with the FDA does not scream competence. It makes me think what else are you hiding.
If you want help in making sure your medical algorithms are compliant and want to get through the FDA, reach out to me here.
