QMSR Masterclass: What You Need to Know (Webinar Replay)

Hello, and good morning. Welcome good afternoon. And depending on where you're calling from. My name is Shawn Smith, publisher of meant tech leading voice. I like to welcome everybody to quality management system regulation masterclass with Michelle Lott and Angel Bundy. Welcome, both of you. I'm gonna go ahead and launch a poll question because that's Wow. poll. Question one watch. Give people something to do while there. Logging in and getting ready. In the meantime, I'm also gonna post in the chat, so I'd like to encourage everybody to use the chat to say what country they're coming from, and then

everyone

tooth.

I've put some housekeeping notes and speaker contact information in the Webinar chat. I'd like you to feel free to use the Webinar chat, or or the Qa. To ask questions throughout. We may not get to all the questions during the webinar, but we will do our best to follow up with you afterwards. And while we're waiting for everyone to join it looks like a lot of people are joining people are joining from all over the world, and very excited to introduce Michelle and Angel. Michelle. Why don't you tell us a little bit about yourself or no angel. You go first because you're

on the screen.

Okay, perfect. Thank you. Thank you. Shawn. Yeah. So I'm Angela Wendy. I'm the knowledge manager that's alive. So before we jump into the main training session, yeah, from Michelle about Qmsr. I want just to talk about a little bit about how sound life can improve or Oh, implement. Yeah, your quality quality, quality management system. Alright sign life for those who do not know us yet. Right is a quality smart.

Platform. So a smart quality platform, indeed.

So it is a management software that is designed for the license industry. Okay. so the first thing I want to ask you is. what is your company's biggest challenge in terms of quality. Just just think about it. So this is not a poll. So it it. It is compliance, or I know, as compliance with the Qms. Are, or it is about efficiency or political culture. Yep. is there any other challenge? Okay, think about that just for some seconds. Because at Silife, what we have seen when talking with our our customers is that quality is seen really, as a necessary evil. Okay? And for some companies, it is a cost of doing business. Okay?

And I think this is a very big challenge. Okay. next next slide. And why? It's that because regulations make quality mandatory. And we have seen at highlight that many organizations still have a traditional quality mindset. They they have a quality department, right? Every everybody has a quality department, but some of them only focus is on compliance and not specifically on quality. Okay. So for them, it is difficult to measure the direct costs that are related to to failures, to deviations. to kabas. Yeah, I find out to, to, to comp to complaints. So apart from

quality people, nobody sees what the company does in terms of quality. Okay. So the second challenge is having the right quality mindset just to be on board with quality on all the quality initiatives. Okay. so organizations need that everyone is responsible for every related task that is, yeah, related to to quality. And what we all need is that people is proactive in regards to quality. Okay. next slides. So what do we do? What what can silive offer for you, Psylove?

What we have is a smart quality platform.

and our target is to transform the mandatory polarity processes into a competitive advantage. Okay. this is the key driver for valley creation for us. And that's why we have a full integrated platform with different solutions. You can see there. So with silic, you can track every action you do in your quality processes. You can track every document. every deviation, every Kappa. There are a lot of quality processes to track finally, what you want is to be ready for inspection. But not only that. Okay. We also want to ensure that people add value into your quality processes while the tool, while silic, is working behind the scenes. Okay.

next slide. how do Silas comply complies with regulations mainly in the industry what you have to comply. If we have a soft worries with 21 Cfr parts, 11 from the FDA, and we also incorporate the electronic signatures. We also have another trail incorporated in our Eqms. That tracks everything there, any modification, any creation, any task you do in into the system? Okay? Right next. So sun, life, compliance with all these regulations. we comply with good good manufacturing practices, with good distribution practices, deliberatory practices. Yeah. Gcp, clinical practices. And there are a lot of license, also standards that we comply with, and also with the Qms as well. Okay, so

here is where Salaf can help you in case you need anything and anything from us to improve your quality management system. Yeah, in line with the Qms. And also if you want to transform your quality culture. Okay, so today, we are going to talk about the publication of the FDA final rule for the quality management system regulation. And this is the next part that yeah, Michelle will will do will do. Now.

Okay. thanks, angel. So I am, Michelle a lot. I'm the principal and founder of Lean Req. We specialize and helping primarily start up some small mid size. Companies navigate their regulatory and quality compliance. so I have been in regulatory quality for over 10 years. II did serve a term on FDA's good manufacturing practices advisory committee, and then I make a joke that I'm a master brief counselor, because everybody gets upset that there are regulations. This is my executive team. At present they're playing in puppy Russell death match on the other side of my desk. So I apologize for any extraneous noises for distractions.

So today we're gonna go through the facts of the Qms are what's in a name, anyways. So we're gonna talk about differences in interpretation. And we'll go through all the burning questions and then secrets to success. So if you look at the historical timelines associated with the Qms. Are for a long time the Qms. Are stayed on change between 1996 and to the present 1996 was when they issued design controls and a few other things into the Gmp's. Or good manufacturing practices. That same year was, when Iso, 1345, was published and it has been updated a few times since the original release in 1996,

and the most recent is the 2,016 version that was updated. And then, right after that, they also released a practical guide to help you interpret the 2,016 version. Now, what's funny is that the 2016 Iso standard is like 28 pages, and the Practical guide to help you understand the 2016 28 pages is 228 pages. Of context around it. So and then today, we've got it where they all came together. And so so finally, where the parallel lines have eventually converged here

and then. But at the same time you've got 14971 that is moving in parallel and still in parallel, because it is not going to be codified. So why did the FDA do it now? Well, they did it to eliminate the redundancy and inefficiency of having multiple standards that you have to be compliant to. And I think that this is funny. They they think that it's gonna say, medical device companies, at least 430 million dollars over the next decade. So I don't see how this is. Gonna be that big of a savings, because actually, it, it's gonna get quite complex, as we're gonna see in a minute here.

So the Qms. Are was published on February second of this year. and you know, on the surface it seems like it's going to be like teaching an old dog new tricks with the FDA, because the the Iso and the Iso are an approach already different than Then the Q set or the standard FDA inspection model. But is it really gonna be like teaching and the old dog new tricks. Because, thanks to Covid, we've had like a 50% turnover in the agency. So and they're thinking is constantly involving, and I know an inspector for some that's out of the Phoenix office here in Arizona.

And he's inspected several of my local clients, and I asked him when the draft came out. For the Qms. Are you know what was his plan? Because he's been at the agency, you know, nearly 30 years, and he's like, Oh, I'm gonna retire as soon as that that comes out. So I think we're gonna see even more turnover at the agency. So I you know, it may be that the people at the FDA are gonna get to be, you know, not even know the Q. As the original Qsr. Or Q. Sit, they'll just be new people that were trained to the Qms. Are, and whatever inspection methodology they come up with. So if we, if you know, think back to that history of the Qsr. That has evolved into the Qms. It was always all about the preamble. The preamble was the original comments to the Qsr. They were over 70 pages of, you know, quote recommendations

and they were what the FDA continued to go back to every time they needed to say, Oh, well, when we said this, we really meant that. So even though the preamble was not codified, it, it reflected their current thinking so essentially, FDA was waiting on the Iso regulation to evolve into what they were already thinking and articulating in the preamble. So how elaborate. Does this compliant does a compliant Qms need to be? Well, you know, it should be based on the risk of the device. The complexity of the device in the manufacturing process, and ideally the size and complexity of your organization.

But if we look at the comments in the Qms are, there are 2 that that really stand out, and though those are that they are, while they're not codifying 14, 9, 71, or any of the other standards referenced in the Qms. Are. or the notes referenced in the Qms. Are. Both of these things are needed to understand. The provisions of the Qms. Are and what the FDA meant to say. So there's like 2 halves to the whole, and that that the Qms. Are is made up of an acknowledgement of Iso, 1345, and the definitions from Iso 9,000, and both of these as a whole, make up the fundamental of the Qsr.

But if we go back to those comments. You know, if we we've got Iso 9,001 to consider Iso 1345 to consider. We know that when FDA is talking about risk based specifically said, if you want to know what we're talking about for risk in the Qms. Are, you need to read 14 1? And then I said, if you wanna know what we've meant when we adopted a particular section of the the Iso standard, you need to have read the notes. So now we we know from reading these comments, we've got 9,11345, 14 and the notes.

But so now, if we look at the understanding and concept of risk, and the the 21 Cfr. 8, 20, and the preamble for we have a single instant of the word risk in the actual Qsr. And 36 references to risk in the preamble. So again Fba kept going back to the preamble of for at the time saying all that one time, we said risk in the regulation. We really meant all of these things in a minute, not just about risk and product development, but in also your quality system. So what does Iso have to say about risk? Well, Iso mentions it 32 times in the 2016 version, but most notably is where it talks about a risk based approach for how to control your quality management system.

So. But now we still have risk being mentioned more in the preamble and the Qsr. Than in Iso. So if we we now look at how this pie is evolving, because now we need to go and refer to the practical guide, because the practical guy, like we talked about earlier, is the context in which you should interpret 13, 4, 85. So now we've got 90134514971 notes, and the practical guide that you all you need to understand to understand the Qms. Are. So if we look at the concept of risk.

risk is mentioned 246 times in The Practical Guide. Compared to that that 32 times and 13, 4 85. And this is fairly significant, because, like I said, the practical guide is 228 pages. So they are talking about risk more than once per page. So again, you've really got a perspective of where the FDA is going and their understanding and expectations around risk management and your quality management system, not just product development and product design. So if you compare the. So now we've got a perspective about the 21 Cfr 820 and preamble and the combination of the Practical Guide and 1345,

and what it means for your risk-based approach. So now, if we're looking at the big picture, we've got to look at. The comments to the Qms. Are as well, because these are the new preamble to the original. Qsr, so I think the the actual Qms. Are. The actual regulation now is only a handful of pages, but if you count the comments, it's over a hundred pages so, and those are critical to understanding the FDA's decisions. Interpretations of the Qms. Are itself.

So this chart is from the FDA. They say that these are all the similarities, and that they're harmonizing these former subsections of the Qsr. Into these clauses with 13, 4, 85. One of the comments that I thought was particularly funny was that they said that they, the FDA, did not think it was worthwhile to map the comparison of Cfr. Part 8, 20 to 1345, 26. They didn't think it was a worthwhile exercise, except for that. In 2,017 they they committed FDA resources to city on a Amy committee to put together a white paper that maps the 820 to the 1,345. So be be be mindful of this and and go get it because the FDA did participate in this back in the day. So this this is where to find the actual map

so. But unfortunately, your search for the Holy Grail still continues, because compliance with Iso, 1345 does not mean you will fulfill the Qms. Are because there are some significant differences. And so now, if we look at how elaborate does that Qms need to be, it's going to need to be significantly more elaborate than it had to be underneath the Qsr. Alone. because the bigger in the bigger picture, the the devils and the details, because not only now do we have to consider all of those other things just to understand the context of the Qms. Are, we also have to understand the differences.

So the main differences are around the electronic signature requirements, the compliance monitoring udis and then that there are a few others. But we're gonna delve into the differences and interpretations specifically discussed in the comments. So what's in a name, anyways? Well, there are some significant differences in interpretation, and and the biggest ones are around the concept of the device master record versus the medical device file and the concept of safety and performance versus safety and efficacy. So in terms of the device, master record. The FDA said that that they feel that the Meta, the concept of the medical device file will not be overly burdensome. And so they're gonna adopt that in lieu of the device master record. And they're also going to let go the requirements for the design history file device, master record and the concept of the device history records.

So on the surface, if you read 13, 4, 85 alone, the M. The concept of MDF. Does not appear to be overly burdensome, because really the main difference is the addition of including the intended use in the MDF document. But, like we talked about, you need to understand the concepts that are embodied in the practical guide. Well, in that case, that you also need to consider all of these things in the contents for your medical device, po plus some. So it gets really lengthy and and can be really tedious to develop a medical device file depending on how deep you go into the interpretation of the practical guide.

So another key difference is the concept of performance versus efficacy. Efficacy is in the original Fd and C act. And if you look up the West Webster's definition for effectiveness, it's about purch producing a decided design. Divide a decided, decisive and desired effect, whereas performance is just at the fulfillment of a client or an execution. But the FDA says that the word performance encompasses the concept of being effective as well, and that manufacturers are not relieved of the burden to prove that they are both safe and can perform, and safe and effective.

So more semantics is they are replacing the term establish and 8 20 with the concept of document. And 13, 4, 85, because they said that document, it's implied that it is implemented and maintained. So another interesting change is that they have adopted and added the concept of customer in the scope of their definitions. And so they're they're adopting the the definition from Iso, 9,000 for customer. And it's based which makes you think just like like, you know you're you're a consumer, a client, a end user or retailer. So you're purchasing a good or a service from somebody.

That seems perfectly logical. Right but but they put a a spin on it. FDA did in that. When they are using the term customer property, they're using it to mean that manufacturers must comply to ensure the safety and effectiveness of the devices being manufactured. So then they go on to give an example that I had me and 4 other people on my team scratch in our heads about. What did they even mean here? And when they cause that, their example says, for example, a manufacturer is expected to ensure that the integrity of a component provided by a contract manufacturer is not compromised before it is incorporated into the device being manufactured.

Well, to me. Your contract manufacturer is your supplier, and you control them from your supplier controls, procedures, and you control the product through your incoming receiving procedures for through verification of purchase product. So I still have not figured out this one and what it meant, and what. So it's like your customers, your supplier. Your supplier is your customer. You're the customer you're it's just kind of a little confusing mess. So they also let go of the the wording management with executive responsibility, because they said that the concept of top management discussed in Iso 13,485 embodies the same concept. And they said that top management is responsible for ensuring this culture of quality

by demonstrating behaviors, attitudes, activities and processes that are going to support the quality management system and the product for service provided well, the problem with that is, you know, most of you are probably familiar with Dilbert and his boss. So the 40 haired boss you know, to me encompasses the idea of management with executive responsibility, and I guarantee you like Dilbert, he's gonna put the top management hat on. Dilbert. And Dilbert Dilbert will be the one to go down the ship on that one. So this one is also a significant. It is the term correction. FDA has adopted the concept of both the the Iso concept of correction, corrective action, and preventive action, all 3.

So now, when they say correction, you have to be very specific. Are you talking internal like your scrap, your rework? Non internal nonconformities. or are you talking field correction per 21 cfr. Part 806, so just be be mindful of that. Your procedures need to address this, and when you are taking a correction you need to be very specific about, was it external fuel correction? Or was the product still within your control? So we are. The FDA is maintaining the definition of labeling per the Fd and C act.

But, interestingly enough, they are not going to suggest a definition for marketing, because they say that a separate division, a definition for marketing is unnecessary because it's not addressed in Iso 1345. Well, just because Iso, 1345 doesn't address it now doesn't mean it shouldn't have so I think that this was a a miss for the scope of this Qms. Are. So we have other definitions that are now missing in action. They are not going to include process, validation or design validation, because they say that the concepts embodied in 13, 4, 85 imply process validation and design and development. So it's really important to understand the concept and intent

behind the sections of 1345. So again, you know, I'm gonna refer you back to the Practical guide to get more concepts and understanding in these areas where they're not clearly articulated anymore. It's not all bad news. So one interesting thing. They they did not continue with the concept of an independent design reviewer. So you don't have to have that independent third party anymore, or independent party. For the manufacturers who already have an iso certification and are distributing outside of the us. This likely will make your life easier, and because these are now regulations, the Iso. 1345 and 9,000 are available, and view only read only versions for free.

But FDA says that they realize they have a lot of work to go to do to align the rest of the policies, procedures, regulations guidance to be consistent with the new coup. Qms are so just over the next years. You know, be prepared that you're gonna get a lot of changes to to these documents, and the ecosystem around the Qms. Are. So now let's jump into the the most burning of the questions. So because there are many, and we're just gonna scratch the surface here. But these are the. These are the the lowest hanging fruit. In fact, these are probably the fruit that's already laying just right on the ground.

So will FDA accept Iso 1345 certifications in lieu of audits. Oh, I'm sorry, Shawn. I got in my groove. Do you want to do a poll question? Okay, I'll keep going. So will FDA accept Iso 1345 certifications in lieu of audits. So no, the FDA is not recognizing isl. 1345 certifications. They are a part of the medical device single Audit program, which is based on 13, 4, 85, and for those of you who don't know they accept that audit reports and they audit the audit report. They don't. They're not like help Canada, who accepts just the certificate.

So, but even if you don't get in this app certificate, or Iso 1345, you are not. You don't have to seek certification, but you do still have to modify your Qms. To comply with 1,345. So the intended timeline, the rule is effective 2 years after Puppi publication. So we're looking at February twond of 2026. That it will be mandatory, and the FDA plans to do a hard stop on the Q. Sit or Qsr. Inspections and switch to whatever their new methodology will be.

So I'll pause just a minute and let you guys answer the poll question. So this next one is is really interesting to me. So the FDA is now they can inspect management, review, internal audit and supplier audit records. So there are no more exemptions. So make sure that you verify the completeness of your management. Review agenda including risk management, because

14, 9, 71 requires that your risk management process and procedures be evaluated. Now, you don't necessarily have to do that in management review, but that that's just where I put it. For the ease of of making sure it gets done timely. So there are no more exemptions. So these are, you know, traditionally, these to be pencil with activity sometimes. So. But now the FDA can really dig in. So it's a fine line because you wanna make sure that these are value add activities. But you also don't necessarily want the FDA inspecting them all. And they said the reason why they made this

change was because it shouldn't be a big deal, because all the other regulatory jurisdictions have got the right and access to it. So the FDA should be able to have the same access. So again, under the Qsr FDA, typically did not have visibility to some of these records, but now they have visibility to everything. Yup. And so here they say they don't think that this is a big deal again, because they're already being made available, and the regular force of business to other jurisdictions. So what happens if Iso 1345 is revised.

So now that FDA has Incorporated Iso, 1345. They specifically said that any future evalu changes would not be automatically adopted, but would have to be evaluated in and of themselves to make sure. Whether or not the Qms. Are should be amended. So what does this mean for our harmonization? Well, here we are. Now we, you know, we finally the parallel lines came together. But it it means that, you know, every 3 years they look at Iso to decide if they need to revise it or not. So it means that this could very easily, you know, get de harmonize just as long as it quick quicker than it, it took it to get harmonized.

So now you also have things that are a requirement that we're not a requirement underneath the Qsr. Give me a second for this poll.

Sorry to interrupt. I just wanted to make sure that we got this in when we were still talking about the Isos

Yup. So now, things like quality manuals are a requirement, and they were not a requirement underneath the Qsr. So you know, at minimum, this is a whole new procedure that that you will need if you don't already have a quality manual. So what about Qusive or the quality system inspection technique? Well, the FDA has not published or announced their intent with they they have not published or announced their intent with their audit methodology. However, it's it's highly likely that they're gonna adopt something. Very similar to the task based audit model. Compared to the the Qc. Which is more of a

a system perspective. Now to me, I think that the queue said audit methodology is much more meaningful than the ta task based or checklist based audit. So I'm really curious. how this is. Gonna change both the process and the expectations, and how that the FDA is going to move through their audits now. So hopefully, we have answered the the bulk of the burning questions. And now we can talk about some secrets to success. Sharon, do you have any any other questions you want to put up.

I have one last poll question. If I can go ahead and figure out how to do that without

yes.

there were a few questions. that were shared in the Q&A. One that you may be able to address will the risk management file, replace memo letter to file

no A letter to file is a whole separate process that you have to go through. There's a particular FDA guidance that has got some flow charts in it and based off of what change that you're making. That's you. You will write a letter to file if the change that you're making doesn't require you to make a new submission. Excellent.

you know. And then the poll share the results. 54%.

Yes.

there we go, stop sharing back to you.

Okay. so here's some secrets to success. So the Qms. Are, you really need to understand? The Qms. Are comments, because, again, that is the new preamble. So that is what the Fba meant when they adopted the Qms. Are in Iso, 1345. I also personally feel the practical guide is essential, because that's how you're gonna understand the 1345 and everything that they didn't say but meant to be perhaps be proactive. 2 years is right around the corner. You not only need a runway for the transition of your procedures, but you need time to get your, you know, start creating records underneath your new procedures. So that you've got some compliant records that are available to be audited when they

they get done. So once you transition your procedures. I recommend a mock audit to to make sure that you didn't miss anything. Your and that your records and procedures are transition is complete. So you know again, I my hypothesis is that they're going to adopt the Mds app audio model. So you know. Get yourself familiar with that and comfortable. And being inspected underneath that audit methodology at the very minimum, you're gonna need to update your quality manual, your management review procedures your monitoring and measuring of your process

controls design and development records your cap and non performing product. And you know, one of the biggest things is just the alignment of the definitions, definitions, the definitions think that that is. that aligning to the definitions, but also the concepts that are changing is going to be a key to being successful underneath the Qms. Are. So we are working on a cheat sheet, that is, if you are us only these are the things that you need to do versus if you are already 1345 compliant. These are the things that you need to. that that you're gonna need to align particularly around the definitions. So just shoot us an email if if you want a copy of that.

So I have a lot of downloads and tools available on my website. So be sure that you you check these out and then let me know how I can help. I can

and see.

Ii can help. I can help you transition your procedures. I can help you with your mock audits, and we also have fractional qualities, man quality services where we can be essentially your outsourced quality team.

Excellent. Thank you. Michelle. We have a few other questions. That we should be able to knock out relatively easily. When does the Qmsr come into effect in the Us.

February of 2026? That's when it will be required.

Okay, does the FDA mandate clinical evaluations for all medical devices entering the Us. Market under the new Qms. Are similar to Emdr and Ccr.

no, they have not changed anything about how they classify or regulate product, and what products do or do not need clinical trials.

And then the next question, we are based in Europe and our Iso. 1345, certified. Would that be beneficial if we want to launch in the Us. Under. Qmsr. How big is the gap?

Yep. there there is. The biggest gaps are the ones that we went over here. But I think the biggest thing is to get that alignment on definitions. And then, also, the reporting is probably going to be the biggest significance that you might not already have in your phone management system.

What happens if your transition? If you transition your procedures, then you have an inspection by the FDA. Under Qsr.

Well, the the FDA will tell you that the the Iso 1345 is already kind of, reflects their their thinking about how quality management system should be regulated. So by being compliant with the Qms. You won't be out of compliance with the Qsr. Right?

Good. I understand. this is this is an interesting question. Lots of companies just underwent. MDR. Transitions. Does this just add to the continued wave of regulatory changes that companies are overwhelmed with? Or is it much ado about nothing.

It, I think it definitely adds to the conundrum of what to comply with when maybe you need to comply with it. And and you know that that those pieces of the pie that I have that just can make went around and around. That's just to understand the Qm. That's hard, you know, once you get into these global regulations, you know, you could add another piece for the Mdr. You could add another piece for Brazil. You could add another piece for it. It just it. The more err geographies that you're in, the more complicated it gets. Yeah, I saw a question about Mt.

what the alignment with that was going to be, I think think that's what I saw.

Yeah, II think that that's gonna be that if the FDA doesn't adopt him to sap audit model directly that it will be very similar to

hmm.

I don't understand this question. Perhaps you do. Can we still use Dmr, DHR. And D Hf. Terms if we want. I don't know what that means.

I am sure you can. So those those are the kind of file types. The FDA is letting go of those concepts. You can use those words because FDA says that they didn't need those words because the concepts are already embodied within the 1345. So I'm sure you can call it whatever you want. As long as you define also what a medical device file is, and how you're

compliant with the new requirements.

Okay, I would say that there's Cannipia's short survey at the end of the thing, so it'll it should pop up on your screen. Let's see if we have. We have more questions. So you already answered this question in a way for our product that is intended to be certified during the transition period. Can we aim straight at? Can we straightly aim at the Qms. Are? The answer is, yes.

that

one does not negate the other. It enhances right? Okay, just wanted to make sure that does any consultancy need to be certified. Further, our consultancy was just certified for 13, 4, 85.

There, any other Qms are only regulates products and services that meet the definition of a medical device

understood. Do you have to follow their definitions? Or can you also sharply define your own definitions? As well? Not clear what that means?

You could probably add to. But you can't take away from

Umhm. Right? It's what we talk about about recommendations. Are they really recommendations, you know. If if the F Fta is recommending it, you should do it

right.

okay. Well, that looks like it for the questions. Angel, do you have anything that you would like to add, as we close before we go to the survey.

Yeah. yeah, I think. Yeah, that Michelle has come. Yeah, summarize. Very well. All the requirements. Yeah, we have 2 years for getting ready for that. Obviously. Yeah. the data is just around the corner. So as soon as you can cope with everything the better for anyone. Right? So II know that. Yeah, Michelle, I have a question because I think that the idea has also to to modify or amend. Documents related to. and that are, yeah, not in the regulation. But yeah, they're part of the system. Right. So do you know, when are they going to change the documents? Do they have a plan?

They do not have a plan, and I will tell you this I had. I'm the Us. Agent for several companies, and they they were working on a a contract, and they're like, Oh, Hey, we just need you to say that you're scoping. Your Us. Agent includes these things. And I'm like. No. Per the FDA website. It includes these other things, but not those things. They got that from a regulation that the FDA has not taken off the books. But they have another regulation that said that regulation doesn't apply anymore. So and that's from like it way over 10 years ago. So who knows when you're gonna get

around to it?

I would just like to remind everybody that the slides and the recording will be shared within 24 h by email, to all registered participants. Additionally. you know a number of us will be posting the recording to your Youtube channels or websites. So you know, you can. Look look for it there. And I think that's it. Yes. thank you both very much. For your participation. If you have any, follow up questions. You know. Please reach out to silite for Michelle, and we're gonna sign off. Thank you. All fair participation. Stay tuned for the survey.

Thank you very much. Bye.