When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026

There you go.

Okay, here we go. Hey everybody, welcome. You're gonna have the opportunity to be promoted to… Whatchamacallit? Panelist. If you don't want to be promoted to panelist, just decline. That'll happen in a minute. Make co-host… Confirm co-host.

Okay.

And… okay, so now there are… The number of people in the… I see Kim and Martin. Looks like a lot of new people that I don't know, Well, welcome everyone, and Michelle, Tiana, nice to see you. Now, Michelle, you're in Tucson. Tiana, where are you?

Pensacola, Florida.

How's… how's the weather there? It's a little cooler.

It's cold, it's in the 40s this week. I'm up in the Panhandle, so it's been chilly.

We're in the.

The low here is 40, but our high today is 70.

Oh, okay. I have my telephone set on, Celsius, so then I really get confused. Martin? Welcome. How's the weather? How's the weather in Zug?

It was snowing, but it's no snow on the ground, so I guess it's just cold and horrible and wet.

I guess I won't complain then. At least it's just… it's just brisk here.

6 degrees Celsius, which means it's a humidity of, yeah, 71, it's horrible. I, I, I prefer, like, minus tame and dry.

Okay, well, it's 20 degrees Celsius here, which is about 60-ish.

That seems cold for Fort Lauderdale.

It is.

We're all cold right now.

The whole country is having a cold. Snap. Right now, next, next few days is not gonna be super nice. Then we'll go back to the 80s. So, if everybody wants to, like, put in the chat, like, what country they're dialing in from and, what the temperature is, that would be an interesting thing to… temperature on the ground, as we get ready to kick things off in the next 5 minutes. Is Leo here? So, announcement about Leo. So he was doing a 3-day training on 60601 in Carlsbad, California, with Nemco… Nemco, and they just recently announced that that training is gonna be, live

Livestreamed, and the recordings will be available, so if you register, I can send you the link, but the code is MLV10 to save 10%, so just write in the chat MLV10, and I will send you, the registration info to sign up for that. It is a paid event, it's not a free event, because it's 3 days long. And it's a lot of interesting… and Rob Packard is gonna be speaking, as well as Bill Harden, and, so it's gonna be… extensive, but if you want to become the 60601 expert at your company, hint, hint, job security, then, I, I recommend, checking that out.

On another note, on the middle of next month, I believe it's the 17th, the, two of the members of, including the chair, of the ISO… Dis… The… draft international standard 18969 on clinical evidence in the EU. Our clinical evidence, is, We're doing a webinar with them to talk about the draft. 18969 standard, so if you want, information on that, put 18969, or I'll just drop the registration link. More than 200 people are already registered, and we haven't really even announced it yet.

So, that's gonna be big. Let's see… And then, a number of interesting things coming up. Next week, we're gonna be having… Mark Omo come on and talk about the anatomy of a connected device. This is connected devices for non-technical people, so it's really for regulatory and quality folks that want to understand the implications of how your device is connected to the internet, and the obligations, risks. challenges and opportunities that those different ways of connecting your devices, present in terms of cybersecurity, in terms of,

You know, protecting your patients from harm. Etc. So, and then the following week, we are gonna have, two guys coming on from a RegTech startup, one of whom, worked at Meta for 4 years, one of the co-founders, and his other co-founder. So I'm really curious to see their, technology that they've built. For, regulatory affairs, and I encourage you, more information will be forthcoming. And then what we're gonna do, at the end of the… end of February, Elena Kura is coming on and gonna do, Employment Outlook 2026,

And, for, employers and employees. So, like, what's… what's going on in… in the market, and how you can become a more attractive candidate. Let's see, I encourage people to, come on camera and participate, and to interact in today's call. I'm pleased to have, Michelle Lott, founder and principal consultant from LeanRAQA, and, her, her esteemed colleague, Tiana Benson, who is a senior consultant, something like that. I'll… I'll let you… anyway, I'm.

kiosk coordinator is our preferred term for Type.

Right, and your preferred term is grief counselor, so, and I'm glad to have, everyone on the call today. It's one minute till, but I'm gonna go ahead and let Michelle give us a little background on why we decided to do this session today.

Yep, so there has been a lot of interesting trends in warning letters and 483s that we thought would make for some lively conversation with this group. So, we're gonna go over some recent, enforcement trends, and, kind of the perspective that FDA has taken on, different quality issues. Tidy, anything to add?

No, I think that sums it up. It's kind of a, you know, it's not a super long deck today, so like, Sean said, we invite you to talk and participate, because a lot of it is about reading between the lines, just so you can see, kind of, what the focus is on, and what positions, you know, FDA is taking, that you kind of have to, you know, react to as members of industry.

So, we're super interested in, we're going to be talking about our experiences. We're super interested in what your experiences have been, and if they're similar to ours, or differing. So, you know, speak up and let us know what… Experiences you guys have had. Sure. Okay.

You want me to start sharing? Alright. Is it the right side, or do I need to switch?

That's right.

That's right. Okay. Alright. Well… I was like, Sean already introduced us, but here we are again.

Well, we didn't introduce Morty, Lucy, and Lily King.

Yeah. That's, that's the C-suite. Who are, at present, already, hard at work taking naps. hour in. Sorry.

Alright. Well, here's a little bit of the warning letters we're going to cover today. All of them have been in the last year, just to kind of give you guys the perspective. There's a very interesting case, if you haven't heard about it, with WHOOP. There's been a big… Push with registration and listing warning letters, and then warning letters to foreign labs. So, Michelle, I don't know if you want to start.

Yep. So, pretty much year over year, the top 5 things that get 483s are pretty consistently, and they'll vary a little bit in order, but Kappa, complaints, design controls, purchasing controls, and non-conforming product. And so, like, if you think about what's about to happen with the QMSR, under the QSR, these are already the big, big gaps underneath the current paradigm. So, you can expect, when we transition to the QMSR, that if we're already not doing things right under the QSR, that these, findings are going to continue to skyrocket in these particular areas.

So, if we look at the 483 metrics, in, physical year 24 was 672, whereas physical year 25 was 791. Alright. 43s. And so, pretty much you can count on lack or inadequate procedures being at the top of the list. And then, specifically, it goes down, again, consistently to complaint procedures year over year, then, one or the other of those top five, issues.

And we should back up. We started with talking about warning letters, but 483s are what FDA issues to you when they come and do an on-site inspection. So… they're kind of like the non-conformance report for FDA. When they come and inspect you, find that there's errors or issues in your quality management systems. So we're starting with 483s because there's a lot more of them, and they inform where FDA is putting their, like, priority issues, or what they're seeing, like Michelle was saying. So, usually you have a 483, and then you get an opportunity to respond to that 483 following the inspection. And then you can either give the FDA an adequate response by saying, you know, here's our corrections.

or you give them an inadequate response, which FDA then expects you to Discuss with them, discuss what the issues were, and you can have another opportunity to give them an adequate response. But if you give them another inadequate response, you get a warning letter. So you have to usually walk quite… you have to make a mistake quite a few times, usually. to go right to a warning letter response. Then, once you get a warning letter, you get another opportunity to submit either an adequate response, and if you continue to have inadequate responses, you go to the consent degree, which is, like, the ultimate hammer, just to kind of orient you in what the usual workflow is.

That's where FDA basically moves in as your roommate.

Yeah.

So these are some common, wording, and pretty much, every warning letter has got, similar wording, in that your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction and civil penalties. And similarly, they also consistently say, please notify this office in writing within 15 business days from the date you received this letter of the specific steps your firm has taken To address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.

Include documentation of the corrections and corrective actions. So the FDA expects you to be pretty much Johnny on the spot in, in your response.

Yeah, and this is basically out of almost every morning letter. There are a few exceptions, we'll talk about that. But… this is just kind of standard language. When you look at the warning letter metrics, it's actually… There's a shockingly little amount, in my opinion, that get issued every year. So these are the primary quality management system reasons. I mean, design and risk management is almost always the top contender, which is very similar with the 483s, right? So 483's design is one of the biggest issues. I think design and risk is going to continue to be a really big issue under QMSR, because you have so many historic products that have very, very old design history files.

that are going to be expected to be compliant with ISO 14971, even though it's not codified. it's just gonna be a tough spot for people who have historic documentation. And then after that, next one is kind of manufacturing processes. So, you know, they're looking in the right areas where it's gonna actually impact people. regulatory reasons. So… The big violator is always people going… marketing without authorization, or marketing with insufficient labeling or incorrect labeling. So either they say, hey, I have a clearance or something, and then I broaden my scope of what is cleared, and we continue to market that, and FDA says, wait, you actually don't have that covered in your clearance, and we need your new 510K, or you're just blatantly marketing without authorization at all, and FDA says, hey, you need a 510 to make these types of claims, and you need to submit

some sort of pre-market notification to FDA, you know, PMA, 510K, de novo, whatever is the submission that they request. However, we'll talk about these later. You can see there has been kind of a historic moment where FDA issued A 12 warning letters for registration and listing, which… I mean, Michelle and other people on the call can comment, I have personally never seen a registration and listing warning letter. You know, I've been in the industry over a decade now. This is the only time I've ever seen one. But FDA does very much troll your website, and I would say that I am seeing, as a trend.

we're seeing a lot of FDA website perusals and looking through what is available on the internet. So, if you look at the data, they've only… they only issue 54 warning letters for the entire fiscal year. That's not very many, when you consider that there's over 700… Warning… 483s, and then there's, you know. couple thousand registrations and listings each year. Facilities registered and listed.

So, go back. Larry Stevens. Have you, in your.

Yeah, Larry's the one to ask.

Have you seen a warning letter for FDA establishment registration listings?

Yeah, yes, I have. It's unusual, and usually it's for foreign firms, where they ship a device to the United States, and one of the things that the entry reviewers check is, is it registered? The deficiency there is for the importer. Do not choose a company, and if he chooses them, make sure they register with FDA before he ships the product.

Okay.

Did you see that go right to warning letter? Before?

Yeah, it's, it's, easy for the FDA to do, because it's a very clear violation, it's not a.

Stay.

you know, did it, but did it wrong. They just didn't do it. And the control of the foreign manufacturers is very important to FDA.

Yep, and even more so now.

Oh, yeah.

Okay.

Okay, and this is just another table to break down those warning letters. So, they did… this table broke it so that on the left-hand side. Is overall warning letters, and then the right-hand side percentages is taking those registrations and listings out, because it kind of skews the data, because there's so many of them. But you can see, this is right in line with where they're finding 483 issues. Almost all of them are around the CAPA procedures, the complaint procedures, design controls, production controls, and then MDR recall and corrections in the field. So, there's no surprise there. They're kind of, you know, 43s match warning letters, that's what you would assume.

But we're gonna talk about a few of the warning letters that came out in the last year that drove policy and were kind of interesting. So, Michelle, I don't know if you want to present WHOOP?

Yep. So, this one's kind of interesting. It was a, device that, is intended to measure blood pressure, and the company was claiming that it was a general wellness product, and the FDA sent them a warning letter saying That it has an inherent use, or inherent intended use, that is associated with the diagnostics Of hypo or hypertension, and so, therefore, it… they considered it For use in the diagnosis of a disease or a condition. So, one thing that's interesting about that warning letter is that, you know, we're all familiar with the intended use and indications for use, but now the FDA has this unspoken inherent

use to, consider. And that these can, wrap up materials or features, like antimicrobial coatings, Soy, filters. Or claims, including, like this warning letter, the blood pressure monitoring for wellness purposes. And so, the FDA says inherent use is where public knowledge can imply a use to a medical device or a monitoring.

Yeah, this is something that we are starting to see more and more of, especially out of COVID. I saw a lot of this, where they were like, you're adding these components that have you know, properties, even though you're not making any statements about them, people will assume that they have a function, and so you need to address it in your submission. We saw a lot of that coming out of COVID, and You know, whoop blood pressure is kind of… this warning letter kind of followed that trend. here's what WHOP had to say. They said FDA is out of its gourd, basically, and that, you know, they didn't… they were misguided, they were under general wellness, it was actually quite…

Yep, they threw the gauntlet down. It was quite strongly worded. And after that, after the Whoop warning letter, Apple actually got clearance.

Just shortly thereafter.

Yeah, for a hypertension blood pressure feature in their Apple Watch. So, Whoop was issued a warning letter, Whoop is arguing with FDA, Apple gets a clearance, And then…

factors into why, like, that Whoop likely got the warning letter in the first place is because FDA knew that this was, coming… coming down the pipes, and they're like, well, we already are regulating this underneath the 510K, therefore they should, That, that, the, that, the, What am I trying to say, Ty? Well, what happened was… That WHP, like, okay, we just cleared this underneath a 510K, and then, so therefore, WHOOP is illegally marketed, because we have hypertension.

Well, if you look at Apple's clearance, they had submitted in February, and then they were probably doing the back and forth with FDA to talk about it. And then WHOOP got issued their warning letter right between these, so they got issued their warning letter in July. So FDA, when they were doing their review, was probably either pointed in that direction, or was doing their own organic research. to kind of determine which way they wanted to go with this feature, saw WHOOP, and they said, well, if I'm gonna clear a 510K, for this feature, why wouldn't I also market the same device under those same scrutiny? I mean, it kind of makes sense, but there's a little bit of reading between the lines, and where there could have been some espionage, it could have been some finger-pointing, who really knows?

What does the wellness guidance say? Joseph asked, did Apple turn them in? We don't know. We're just reading between it. There's no way for us to know. There's no way to know if Apple said, hey, we know we have competitive features, and we're gonna get the 510K clearance, just to kind of, you know… it gives you a market advantage if you have 510K clearance. In some ways. We don't know, but this is the timeline of publicly available information. So, the wellness guidance. The wellness guidance has been around for a long time. This is what it says, you know, it's about… it's about… Enforcement discretion for general wellness products that are intended to help

you know, support a healthy lifestyle, or help living… like, doing living well with a disease is basically the two categories. So, either it's completely health and wellness. or if it acknowledges some sort of disease or condition, it's only to kind of live well with, and these are the big exclusions. It doesn't identify or name diseases, it doesn't put out characteristics as abnormal, pathologic, or diagnostics. It doesn't include clinical thresholds, which this one's kind of hard, because you'll see, we'll talk about What happened to this guidance, and then it doesn't provide any ongoing alerts or monitoring to manage these conditions.

Well… this January, just a couple weeks ago, FDA actually updated this document, this guidance document, and it now explicitly has a blood pressure example in it. So, blood pressure… As a wrist-worn wearable product. And while pulse rate and blood pressure are measured via this very long word, photoplethiosimogram.

Say it 5 times.

Is now explicitly a wellness category, so… That's very interesting, right? If you look at this story. Apple submits their 510K. Whoop gets a warning letter. Apple gets clearance. But then in January, FDA revises this guidance to clearly allow WHOOP to be a wellness product. Also, in January, FDA announces the Tempo pilot, which is this risk-based initiative, risk-based pilot, that is for expanding digital health devices. To support chronic conditions, and…

I have mixed feelings about this, because the chronic conditions they list are pretty high risk. You know, it's for cardiometabolic, musculoskeletal, and behavioral health. And what the intention is, is that… Patient Monitoring Digital Health Devices for Home Use. are going to be given some sort of enforcement discretion for their pre-market notification, meaning that the… they are going to align with FDA to have less requirements. To sell their products so that they can get real-world performance data. using this risk-based approach in alignment with FDA's policy. And FDA also is going to follow the CMS access model so that there's hopefully

You know, reimbursement for these devices and everything. It's kind of a double-edged sword, because it means that… You might have less requirements for these at-home-based monitoring systems for cardio You know, vulnerable people, or musculoskeletal vulnerable patient populations. But… there might be a need here, and that it's just not being met. That's why FDA put out this Temple Pilot, because there's a recognized understanding that you need more devices in these spaces. We need better patient monitoring, especially in a home-based care. So, they've announced the Tempo Pilot in January. Well, they announced it in December. It's open in January.

So if you follow this whole timeline, it kind of, like, paints the picture for where the agency is today, January 2026. It's… It's definitely a shift in policy, so we should have had one more dot here, which is that Apple submitted their blood pressure, 510K, but then Whoop gets a warning letter, which is where FDA's position was in July of 2025. Whoop disagrees with it. Apple gets their clearance, and they're still the only product that has clearance under that product code we checked. And then… FDA announces this tempo pilot, so it's basically saying that they want more products in patient monitoring. They want more products in digital home healthcare.

And that they are intending to work with industry to do an enforcement discretion policy to determine what the real controls around those devices should be. And then they update their general wellness guidance explicitly for blood pressure monitoring, which used to historically always be a clearance product. So, you can see there's kind of a deregulation shift in terms of digital health software patient monitoring is what I'm inferring from that. Larry, I see you're nodding your head. I'm sure you have a lot of feelings, whether you want to talk about them or not. That's just the trends that we see.

And I don't know if anyone else is seeing any of these sort of trends, too.

Well, I think you're very accurate in the deregulation thing. That's a general discussion within the government now.

Yeah.

the key is risk-based approach. In other words, the FDA is… Really focusing now on risk assessment all through your company, and that's what they're looking at, is Do… does the product itself Present a direct risk to the patient. Now, and if it does, then they're going to take action, but if it's this indication of blood pressure, doesn't really put the patient in any danger. The only way would be would if it gave us a… a false, low reading, and says, you're in good shape, don't worry about it, and they have a stroke afterwards. So, you can theorize it, but…

the deregulation is what this is, and I don't think it's bad. I think… From a business perspective, it's a reasonable thing to approach.

On occasion… yeah, I mean… It's kind of an interesting… area, because I think about blood pressure, and I think about these wearables, right? And under enforcement discretion, there's really no performance data required. And I think about my husband, who does have high blood pressure and does take medication for it, you know, he has the cuff at home, has to do a log. Not so much anymore, but I think about if people start relying on these watches and there's no performance data, does that cause an issue? And I think that there's just got to be more transparency and more awareness with consumer purchases.

And knowing when you can trust a consumer product versus a medical device for medical purposes. I think that's gonna be hard for the public to navigate. Because when I was doing just research on this, you know, I like to… I am a self-proclaimed nerd. I was like, well, what are the performances for WHOOP? I'm, like, really genuinely curious. And lots of people in the threads were discussing how WHOOP was consistently off. I mean, this was a while ago, and this is not my own testimonies, but that they had to rely on their at-home blood pressure cuffs to get accurate readings. So, it's just, it's an interesting…

area for consumers, I think, that don't necessarily have the medical literacy to know what they're purchasing and how accurate something is.

So, before we move on, I wanted to see if anybody had any comments. I was gonna comment that, I took the last screen about the, the pilot program, and did a screenshot of it, and then put it into ChatGPT and said, say more. And the most interesting thing that they had to say was, at a higher level, tempo reflects a broader FDA posture. Ongoing evidence beats static documentation. Life cycle thinking outweighs one-time submissions, and real-world performances becoming a regulatory asset. You know, I've been saying this for several years at this point, which is, you have all this evidence once a device hits the market.

And the clinical trials are, you know, 300 people usually at most. And so, you have this gigantic data set around performance and adverse events, and it's just really underutilized, not only by The… the regulatory bodies But by manufacturers themselves, in… in terms of finding new market opportunities, and… You know, really… competitive advantage. I mean, it is the key… To everything is the perf… how does it perform in real life?

And so I thought I'd just derail the conversation with that.

I think there's a lot to be… but, I mean, I think there's something to be said for that, because something that we all see is… you know, there's a balance and a struggle between the agency and industry in bringing things up to the current state of the art, right? Because you do a one-time submission, and maybe your 510K is 20 years old, and then by the time FDA comes to audit it, it's like… you are making practically a whole new device sometimes by the time FDA comes and audits you, because you've had a design change here, a design change here, a letter to file there, a letter to file there, and then it's like, oh, my biocompatibility testing's 40 years old.

and I realize I've changed manufacturers, or something like that, and maybe I have, like, just an increase in rashes. You know, there's a lot of things that… proactive… documentation and, like, collecting real-world data, I think, with the FDA subsystems is really underutilized. Yeah, Martin, you gotta…

Yeah… In… back in 2… around about 2010, I read some… I'm… Ms. Waterhouse Cooper's publication, which was talking about continuous evidence, would come. And… I think we're seeing that right across the industry. And so… What is it? It's not unreasonable to ask for post-market information. If a company doesn't have enough information, then the agency says, well. Yes, we'll give you a provisional Approval, but you have to deliver post-market data. And what we see in Europe is post-market surveillance. So, really, for me, this is all resilience. It's all coming down to

Continuously monitoring your product in the market, and making sure it's safe. How can you make sure that your product's not safe without continuously monitoring it? Okay. Makes sense.

Yep. There's also been some comments in the chat. Hold on. Let me back up a little bit.

So… Sarah asked, how much advance notice does FDA give prior to an inspection? They can show up unannounced. I've seen it announced a week in advance. I've seen it announced a month in advance. And then I've had them physically show up unannounced at least twice in my career.

Michelle, can you read the questions? Because I can't see them, because I'm sharing.

So, then, so that was Sarah, then Steve says, getting the technical files for a virtual manufacturer sourcing from Chinese manufacturers is sometimes difficult. Especially after many years of not asking for them. And if you're a small customer, or they have proprietary concerns, what can be done to remain in compliance? So technical files are a little outside of the scope of this particular topic, but this is a very, big issue with… in Europe for the MDR. Is… and it's near impossible, because they have to give you so much information that they're giving up their proprietary information. So that leaves it on the virtual manufacturer to be able to prove all the data and testing, on their own, and they can't just rely on

The fact that the… Supplier may or may not have a technical file. And Susan says, what about data protection in these cases? I'm not sure… what that means, if that's, like, H… HP…

Data protection? Like, patient data protection? Well, I mean… Whoops. not… doesn't have to have any… from the FDA perspective, it's under an enforcement discretion, so it does have to follow, you know, standard data protection laws. If you purchase, you know, apples, Apple's watch, then they at least would have had to provide all the cybersecurity for that information, which includes data protection. So…

Okay.

Any other questions?

Alyssa says, if you're MDISEP… if you are MDISEP certified, would FDA ever inspect you? How would a warning letter come along?

Oh, Michelle and I have stories about that!

So, fun fact, FDA does not accept MDISAT certificates. They accept audit reports, and then they audit the audit report to determine if they agree with the conclusion and the ratings of the findings or not.

And that is also only for routine audits. Right. So, FDA absolutely will still come audit you, even if you are MDSAP certified. Do not think that your MDISAP certification and report will get you out of the cycle, because FDA, if they audit you for risk, and that doesn't mean that your company is a risky company, it can be based off of the type of product you make. Or trends that they're seeing in industry, or their own internal analytics and analysis. They can still justify that as a full risk audit, or for the organization's audit, and still come in and audit you. We've had lots of, customers who get their MDSAP certification thinking that they'll never be audited because they're getting their MDSAP reports every year.

But… FDA will still come in. You know, we saw this with additive manufacturing, people who had 3D printing, they got audited every single year. We saw that with, menstrual cup clients. They also were high-priority devices for FDA at that time period. And so FDA continued to audit them. Michelle, I know you have other good examples of that, but FDA won't just accept the report if it's an initiative around something that they need to collect, or they've decided that your device is in a higher risk category, or something like that.

Martin, I see you were entertained by this discussion.

Right, because I just took a company through their MDSAT, and I just made it clear that you… You probably reduce the odds that you'll be audited.

Yeah.

But it won't be removed. And I also had an experience of an unannounced audit. Where a company… the marketing people in the company had this great idea to change the promotional material on the website, and it no longer aligned with the IFUs in the product. Which was packaged inside someone else's product. So the FDA then flagged this.

a class.

You know, what's going on? And they call me and say, what should we do? I said, take the website down. And I said, and be ready for an audit. And sure enough, they got an audit.

And it was an unannounced audit, but no big deal, everything was fine. It was just because the marketing people screwed up with the website, but…

Be ready, you know, always be ready.

Okay, so we'll… I'll… we'll… I'll answer these other one-off questions, towards the end, so we can get toward… get through the warning letter trends.

Okay. So we kind of talked about this. Registration and loading… Listing warning letters. Chest binder warning letters. This was… I mean…

All in one day.

All in one day, 12 morning letters came out, 4 chest binders, so… FDA was reviewing websites, it says here, per your firm's website, you can see from all the… the click-ins. you know, FDA was reviewing websites for chest binders, and they came out. The common term that all of them said was to ease or assist with gender dysphoria. I think that they got nailed because they used the word dysphoria in their website marketing. I think that that was probably the internal parameters that FDA had set around writing these warning letters, which is kind of interesting.

FDA considers that a medical condition.

Because, yeah, gender dysphoria is a medical condition. So you need to pay attention to the administration. You know, FDA Commissioner Marnie Macari was already talking about it. When he did his press release, it was a little bit interesting, because he said, you know, marketing these products for children is alarming, which there were no pediatric indications on the websites, we… I mean, or cited in the warning letters. But, you know, FDA is taking enforcement action. This is all… it's kind of a weird disconnect, in my opinion, because when you look at the Class 1 product code and the medical description of it is used for medical purposes.

For the underlying body, and their examples are often for, like. post-surgical, right? Like, they're post-surgical. These are 510K exempt devices. These are GMP-exempt devices. I would think that the dysphoria claim would be even beyond the regulation for this binder. Because it's dealing with behavioral health or mental health, which is kind of how FDA deals with depression and anxiety, right? So, depression and anxiety are different indications, and dysphoria would be a different indication. So… The warning letters were written around gender dysphoria. The regulation is really about being a medical binder, usually post-surgery.

Is the most common registration and listing medical device version of this. The chest binders that were written up were intended, you know, for the transgendered population, helping with gender dysphoria. They're almost, if you remove that claim, they would be not even medical devices, they would be almost commodity products at that point, because there's not really any medical claim around them. So… It's interesting that FDA used time and resources for a Class 1 510K exempt product that's GMP exempt as well. It doesn't even have to follow good manufacturing practices. I mean, your quality management system is basically reporting complaints.

and records. But it tells you that you need to be paying attention to what the administration is doing, because they are driving where FDA is allotting resources, right? So… Keep that in mind.

And, like, how we got to marketing these products for children, we still have not pieced that one together.

Yeah, that is still… Whatever. Foreign labs.

Oh, this is a fun one.

Yeah, so… there's been a lot of issues for years. I would say, what, 3 years? 4 years? Kind of since AI started coming around, when they could kind of massively review old 510Ks, in my opinion, and developed Elsa. data has come into question, right, for foreign labs. Well, FDA is actually writing up foreign labs with warning letters. So two of them have been in China, one has been out of India, they all had GLP findings with them. And this aligns with FDA's announcement, May 6, 2025, that they were going to conduct unannounced inspections of foreign manufacturers.

and facilities, and they want to promote domestic production and re-evaluate the approach to pre-approval inspections. That's kind of beyond this, but they are no longer pre-announcing inspections of foreign facilities. At the time, they had a bunch of RIF actions, so they paused the foreign inspections pilot, but I think they are now starting to do this. And we're seeing this by these labs getting audited, and… Getting issued warning letters for them. And then this also happened with Wushi App Tech. Michelle, I don't know if you want to talk about… the Biosecure Act and what happened with Wuji.

Like, I… I see your warning letter, and I raise you. Like, I did not even know that, this mechanism, the BioSecure Act, existed before where she got its, citation. And basically, the owner of Wuxi, who is Chinese, was funding, demonstrations by the Chinese government. And the FDA said that this is a threat to national security, that they have so much of our data And, including safety data, formulations, all kinds of things. And so, the FDA cited Wushi, and told com- companies it would no longer, recognize data generated by WUSHI.

And then, ultimately, Wuxi had to dismember their U.S. lab and sold it off to NAMSA. Because they were not… even their U.S. lab was allowed to conduct tests because it was all owned and operated by the same, main office in China.

And what's crazy about that is that Wushi was a very credible lab. They were on the ASCA list. For certain things, they, you know, they were generally well accepted by FDA. As with all labs, you've got to pick, you know, who's good at what when you're doing it. But they were on the AS… CA list for certain tests. You know, we've done submissions with LushiData and haven't had issues with it, so… It was, on the surface, a credible lab, but now it's had this Biosecure Act violation and had to dissolve its U.S. operations since…

Larry, have you seen Biosecure Act being invoked? Previously?

No, not really, but I think this is as much political as it is public health. In other words… There's a general move to try and get Stuff done outside of the country, done in the country, and…

Yeah.

I think this is… they use this as a tool. FDA does not enforce the, the… the… Biosurf, whatever that…

The Biosecure Act, yeah.

What we hear is that if you were a laboratory. And you're doing testing that's going to be used as an addendum to a… Approval application. the manufacturer that submits the application has to certify that the laboratory testing was done in accordance with GLP. So, that's… that's how they… that's their tool for sending warning letters, is they saw some kind of deficiency in the data, and It's telling them, you no longer can do testing, it's going to be sent in as part of a submission.

Well, these warning letters were conducted on-site, so when you read them, you can tell that they went on-site and looked at the… the state of the labs themselves. A lot of them got dinged because they reused animals, actually.

Right.

Yeah, they reused animals, and then obviously they… one of them was really bad. It, like, had the study lead also signing that they did all the work, so there was, like, no independent review, and there was, like, weird backdating issues with the study lead. They were, I mean, they were pretty egregious, I'll be honest. If I read these, I would be pretty upset if I had used any of them for my test data.

But… The morning letter would have to be based on… Direct observations of deficiencies at the lab.

Yeah.

That's how they do it.

So, but I think you're totally right, Larry. Like, there's a push to promote domestic production, domestic labs, I think… The trend of the agency right now is to… really push domestic. Michelle and I have seen more issues with imports and customs than we've ever seen before. I mean, people who have been importing product for 5, 6 years, or doing things by the book, they are getting held up, you know, in ports. So, in terms of the agency and where administration is driving it, I'm definitely seeing that there is… A big push towards domestic, and especially away from Kind of, you know… East Asia

Michelle, I don't know if you want to add anything.

Hmm, what's… Let's, get through the… okay, that's…

That's it. We're done.

Okay. Good.

No, go ahead, David.

Oh, sorry. So, I wanted to question a little bit, FDA unannounced Foreign Inspections. I've… when I've been in foreign inspections, particularly in Switzerland. the Swiss Authority also would show up at the inspection, because I understood, that FDA, as a government entity, needed to notify the local federal entity in Switzerland, France, China maybe. prior, and particularly in China and India. you know, give me 3 months' notice that you're coming in, you know, the summertime of 26. I'm fixing my facilities. Quite different than a domestic inspection, where they might be here this afternoon.

Do you have any… Insight on that, or changes to regulations?

thing, I was like, okay, what is the logistics of unannounced inspections? Because most countries require the FDA to not notify them and then get work visas. So, how can you do unannounced inspection when you have to have a work visa, and then the in-country equivalent of the FDA will likely come with them too, and then in turn, notify. So, and to get a work visa, you have to be sponsored by the company that you're going to see.

Kel and I have been talking a lot about this internally, because it doesn't seem like the logistics are well… thought out. So they put in May 6th that they're gonna… May 6th, 2025, that they're gonna conduct these unannounced audits. But I just don't know how they're gonna handle it logistics-wise, right? And then they had such big… layoffs? That… it makes it even harder, because there's less personnel. Sandy said in Canada, there have been unannounced audits, and they just show up. I'm sure it's gonna be country-dependent. Like, we were saying on whether or not they require to have a visa, whether or not they're required to, you know, have translators, whether or not they're required to have any sort of other infrastructure.

So, it might be a case of, if the requirements are low to entry, and they have a goal. to get a certain number done, then maybe, like, you know, our Canadian… Companies are gonna get hit more.

Yeah, I'm just wondering, as Michelle was commenting, I don't re… I don't remember if FDA still has pilot offices. in China, or in India, or other places. Or the rifts have really pulled that back, but I would presume if they had a China-based FDA facility. they could probably walk into a China manufacturer without visas, without Much of anything, but that's a big, big guess.

Yeah.

Hmm.

And Steve, I see in Canada, FDA just shows up, there's an agreement in place with Canada's government. I know that the Health Canada and FDA have been working really closely, because even Health Canada has started their eStar pilot. So, I'm sure it's a little bit different for Canada than it is for other persons in the world for the unannounced audits. Because Canada has been, and FDA have been. leveraging a lot. You know, there's, there's, you know, been a pilot for E-Star in Canada for a while now.

So Kevin says, do FDA audit initial importer in the U.S. and manufacturers outside the U.S. and in Canada? So, FDA does not audit initial importers. And the initial importers don't even really have to have a quality management system. All they have to do is register with the FDA. I don't even think that they have to, like, list the particular products that they're importing. And then Christy says. What if you are a startup using a contract manufacturer, and the startup offices are at the contract manufacturer's facility because there's no revenue yet? Would the FDA inspection only be for the startup documentation, or can they inspect the contract manufacturer?

So, when FDA goes in, first off, they will only inspect you if you have, active registration and listing. And then secondly, they have to, come in with a 482, which is their notice of inspection. And that notice of inspection is only good for the company and facility that is… states on the scope. So, to go and inspect at the contract manufacturer, or inspect the contract manufacturer's operations, there has to be a separate 42 issued to the contract manufacturer. Larry, did I get that right?

Yes, that's correct.

so, and then, Our old friend Ray Walker says, does a manufacturer need to insist that products sold non-sterile to kit packers for surgery and field packs used only by licensed professionals in surgical procedures include IFUs for inherent risk? So, the term inherent risk is just something that we have seen come up in warning letters, and it's usually associated with, inherent use, rather than inherent risk. So, Larry D can… Do you have any commentary on…

Basically, what they're looking at are MDR reports of off-label use or things like that, where there's a certain risk associated with it. Inherently, and in which case, they will go to the company and suggest that they revise their IFU to add that as a precaution. But that… that's… it's all a risk-based thing.

And then if you… but if you… change your IFUs to add a warning or a caution based off of an adverse event, then you have to file a new 510K.

Well, not necessarily. In other words, a PMA, for sure, if it's a PMA product, but the labeling… if you remove warnings, that can get you in trouble from your 510K labeling, but The safest thing to do would be to go ahead and add it as a precaution, and then send that to FDA, say, update my 510K file with this new IFU, rather than a whole new 510K.

Any other questions?

Do you think companies building in health regulatory AI can assist in any way to keep people adequate with the updates and monitoring the regulations? AI has its place. In everything, but the problem is, is that you have to know enough about what you're doing to know when it's wrong, and when it's hallucinating. And, for example, you know, we have a new employee pretty much right out of college. One of the things that he has to do is, like, we have office hours, and he debriefs us every every week about what happened, and one week it was a slow news week, so he was just like, well, I just came across this article, and it was written by Gen AI,

And it talked about the Special 510K program. And the first time it referenced Special 510K, in parentheses, it put SBD. SBD is a small business designation, and it has nothing to do with a special 510K.

Yeah, it was totally messed up.

And then we've also had it quite comedically, suggest, Ty, what was the product that you were looking.

Yeah, I was looking up a patient, like, it was like a riff on a patient identifi- identification tag, kind of. And so I was looking to see if there was a more specific product code for it, because a lot of times when you have… this had an adhesive in it, and a lot of these Class 1s have… requirements against adhesive. And I looked it up. you know, standard chat GPT. It was very confident. It's like, here's your 3-letter product code, here's what the regulation says, here's your regulation, and I was like, oh, that's interesting, that might have saved me a lot of time. So I go over to the FDA product code database, and I look up this 3-letter product code, and it gave me a circumcision tool.

And I went, that is not a patient identifier at all! This is a completely made-up, fake product code with a fake regulation, and if I didn't know where to verify the source of truth. It would have absolutely… been wrong. And, you know, if you don't know what you're looking at, you have no idea if that's… you know, right or wrong. I'm not saying, like, AI… like, I'm not… poo-pooing AI. I just think that there's an understanding of the limitations at where it's at these days, and having a technical skill set will make me better at using it, but might do a disservice for people who are up and coming in their careers.

So, do you expect a change of 483 type and quantity after the FDA inspections under the QMSR? And honestly, I do not… see a difference coming, because underneath the QSR, those top 5 areas were where industry was consistently not meeting the expectations of the QSR. So, if you're not already meeting the expectations of the QSR, you're even further behind the eight ball when it comes to meeting the QMSR and ISO 1345. And we actually have a series of classes that go into a great amount of detail about the differences between the QSR, the QMSR, and the correlation between the… what to expect out of those top 5 areas in 43s.

I think if you… look at the way 483s are already read, too. There's some expectation from FDA in how you are implementing some of this information, because they have to write them so specific. But Michelle and I went through and looked, and we found ones where they were calling out risk, right? And risk… there's only one mention of it in the actual QSR. The preamble talks a lot about it, but the QSR only has one mention of it, and it's with software validation, so it's kind of weird. But I think the expectations is that FDA's already been auditing to a higher level. They're just gonna be able to write their 483s more clearly, because they're not gonna be…

Strong-armed into riding them against 1996 language, where they still use concessions to mean… to mean, like, rework. Or approving without rework. So, I think it will make it clearer when you read your 483s about what the issue is, but it's… Still gonna be in the same trending data.

And I would like to encourage anybody that's interested in learning more about the, classes, QMSR, CAPA, Management Review, what are the other ones?

Complaint recording… reporting and recall is coming soon.

Yeah, anybody that wants to learn more about these classes, write classes in the chat, and I will, you know, send you a link or something like that, or, you know, call you and bother you. No, I won't do that. We're about out of time, and I would, like to thank, Michelle and Tiana for their time, and everybody who joined today. We had, like, 200 people at the high point. And so that, I think, is a record for the Friday call. And… Let's see… next week, Mark Omo's gonna be talking to us about connected devices for regulatory and quality people, not for engineers. And I have lots of conversations with him about the Bluetooth in my car, and how it flummoxes me every time.

So if the Bluetooth in your car flummoxes you, think about trying to use a connected device. And what Bluetooth connectivity, and other kinds of connectivity mean for device users. I think it's an interesting topic, I think it's timely, and I encourage you all to attend. Closing notes, Michelle, Tiana?

I think you're… we're good to go. Someone said if we are beginning in the field, where is the best place to start? I would look at CDRH Learn. If you haven't, I think that's a really great resource for beginners, and it's straight from the horse's mouth, so to speak. In my YouTube channel.

funeral.

Yeah, and Michelle's YouTube channel, the LeanRAQA YouTube channel, has a lot of information as well. So, those are two great resources for you.

Oh, and be sure to subscribe… subscribe to MedTech Leading Voice at MedTechLeadingvoice.com. We're at 8,500 subscribers, so… woo!

Look at you.

Yeah, excitement.

Alright.

That's it? Thank you, everyone.

Thanks for paying.

Have a great weekend.

Friday.

Okay.