Punchline: In a final Trump-era rule proposal, FDA makes it easier (far too easy, in our view) to commercialize dozens of risky medical devices. We need YOU to leave a comment in the Federal Register to reverse the Final Rule proposal before it goes into law.
PLEASE get involved. Don’t assume “everyone else will.” They won’t.
2 Steps. 5 Minutes. Here’s how:
Step one: Download this.
Step two: Upload it here and submit.
STEP TWO: CLICK HERE to leave a comment, as shown below.
The fields are:
Comment: Please find the attached excel file with line itemization for each device under consideration for down classification.
Upload File: Click the [+ Add a file] button to upload this EXCEL spreadsheet.
State or Province:
Organizational Name: Can be “self”
Submitter’s Representative: Can be “self”
Category: Device Industry – C0012
Michelle and Tianna Benson explain: Why down classify?
Joe: Is that mean that which was III is now Class II? That which was II was not Class I?
Michelle Lott: Correct! And so it’s mainly down-classifying from II to I or yeah, II to I or II to 510(k) exempt.
Joe: Remind the kind of people at home, that II is something that is neither invasive nor if misused could kill you?
Michelle Lott: It’s moderate risk. So II is moderate risk.
Joe: And it is like practically none like a bandage.
Michelle Lott: Yeah, bandage are Class I devices unless they have anti-bacterials on them in which case they’re Class II.
Joe: Okay, so FDA decided that there are some 83 items that we previously thought were moderate risk that we now feel is almost no risk?
Michelle Lott: Correct.
Joe: What would be an example?
Michelle Lott: The most shocking to me, in terms of PPE, is surgical mask with anti-bacterial, anti-viral properties.
Joe: I need to process that. So I used to think that if you got that wrong, there was risk and you would be infected, but I no longer think that’s a real risk is what they’re saying?
Michelle Lott: So they’re saying that they no longer feel like surgical masks with anti-viral, anti-bacterial properties pose as high of a risk as they previously understood them to pose.
Michelle Lott: What is surprising about that, is that for surgical masks, they did not exempt, just surgical masks with no anti-bacterial or anti-viral properties from 510(k). So it took a surgical mask that’s more complicated and they’re proposing to not require a 510(k) for it.
Joe: But there are some that are less complicated that still do?
Michelle Lott: Correct. So the bulk of surgical masks that have particle filtration, bacterial filtration, flammability, two other tests that is standard for surgical masks. That category still requires a 510(k).
Joe: Because presumably these are once used in the operating theater?
Michelle Lott: So are surgical masks with anti-bacterial properties. That’s why this makes no sense.
Joe: Okay, so I think you’re saying that masks that have nine properties require a more stringent clearance process than masks that have 10 properties.
Michelle Lott: That is a very simplistic way
Joe: I am a simplistic man.
Michelle Lott: But that one difference is orders of magnitude different in testing that’s required and claims that you make. So every interaction I have had since COVID with FDA on anti-bacterial, anti-viral claims on PPE, they’ve pushed back and asked for $500,000 worth of testing.
Joe: And now they’re saying nah forget it.
Michelle Lott: That they are proposing to forget it. It’s all going to be based off of public comment and FDA and HHS’s response to the public comment.
Joe: Okay, so again as I try to dumb it down for myself, if in my example, the mask with nine things, still needs to be 510(k), why didn’t they make the mask with 10 things still need to be 510(k) except you could ignore the $500,000 expense part?
Michelle Lott: Because the $500,000 expense is the most critical.
Joe: No, no, I get that. But if my goal is to be like, look, the antibacterial part maybe they’re saying that’s too burdensome, so I’m going to alleviate you of that, why don’t they think of it as a mask with nine parts plus one that we’re just gonna to ignore but do all the other stuff?
Michelle Lott: Because that’s the highest risk part. And it’s no better than testing for a surgical mask (indistinct) stuff.
Now it’d be one thing if you took your surgical mask that was already 510(k) cleared, and added some sort of cleared or acknowledged anti-bacterial to it. But it’s not clear that that’s what they’re proposing. It’s like they’re down-classifying the highest risk of the surgical masks, but not the basic surgical mask.
Joe: You included Tianna Benson on today’s call, because she has something to add here.
Michelle Lott: She does! So that was what caught my attention personally because you know I’ve been living and breathing masks. What caught her attention
Joe: Mask singer
Michelle Lott: What?
Joe: Mask singer
Michelle Lott: (women laugh) (indistinct) regulation. So Ti – a whole different group of devices caught (indistinct) Ti’s interpretation of what was the most disturbing things on the list, so I thought I’d bring her on to discuss what she was concerned about in the down-classification.
Joe: Ti, disturb me
Tianna: Yeah I mean, there’s a few things on here that are a little bit intimidating. We see ventilators for continuous use and ventilator support for home case use. And what’s really
Joe: Pieces of equipment that help me breathe
Tianna: These are pieces equipment that help people who cannot even breathe for themselves breathe.
Joe: Sure that went from a III to a II, right? Not a II to a I.
Tianna: So it went from a 510(k) to being 510(k) exempt. And the justification that the FDA is using is their MAUDE database on this. And they’re saying that we’re not seeing any reportable events or adverse events, and therefore we feel like these groups of devices can be now made 510(k) exempt.
Joe: Interesting, so for those of you watching at home, MAUDE, M-A-U-D-E, forget exactly what the acronym is, but basically it’s the library of bad things that happen Adverse Reporting Events.
Joe: And saying that hey nobody’s reporting anything bad, so it must be okay, so we don’t need to be so stringent?
Joe: That’s not exactly intuitive. Maybe the reason that nobody is reporting anything is because we’ve been so damn stringent.
Michelle Lott:: Even Joe gets it
Joe: Even Joe who doesn’t know shit about regulatory can figure it out FDA, are you listening?
Tianna: That’s exactly it. It’s like we’re not seeing reportable events because the FDA is doing their job in reviewing this technology and people who are bringing it to market to make sure they check those boxes. Without 510(k) review they don’t –
Joe: We are so busy with other things right now, we can’t bother with that which we consider to be borderline or marginal, so let’s just down-class stuff so that we can focus on covidy stuff.
Tianna: But that is-
Michelle Lott: Is this COVID stuff?
Tianna: All of this is COVID stuff. I mean, you can’t, you know for a while there was a ventilator shortage. And so they had a whole enforcement policy for ventilators and making ventilators.
Michelle Lott: But in every technology I brought in front of them that was an alternative to a ventilator, that ideally kept you from needing to go on a ventilator, they’re like, “Oh, we did not intend the emergency policy to bring new technology to market.
Joe: Let me ask you to go beyond the outrage and shock of why would they do this? And attempt to answer the question, why would they do this? There’s gotta be something better from your collective minds that we just don’t know. There’s gotta be something. Is there any thread of logic you can think of here?
Tianna: Here is what I’m seeing as a regulatory consultant. It almost is a disconnect within the agency itself. Because when you attend the FDA, PPE webinars especially for surgical masks, just in the last six months alone, the requirements have changed. They have been enforcing the AQL of 4% on all testing, they want to see testing on three non-consecutive-
Michelle Lott: Acceptable Quality Limit.
Joe: Oh, Limit. Sorry…
Michelle Lott: And so it’s taken the masks from testing what? About a total of 60 some across to five tests? Yeah, to it’s based off of your lot size now. And it’s, they want three non-consecutive lots, which effectively at least triples, or more the testing that you have to do. Because you have to do a AQL 4% based off your lot size, on three non-consecutive lots, which means you have to run five lots.
Tianna: Yup and so what they’ve essentially done is changed the testing suite from costing like $30,000 to like $170,000. And that’s for surgical masks. There’s at least one component of the FDA that is moving towards more stricter controls because of, you know their own internal processes. But this document, it’s the opposite message. And so this document is saying that we think that, you know we’re not seeing any adverse events, we think that people are designing things appropriately, so we’re not going to do the 510(k) review. 510(k) reviews are where you catch that someone’s not doing the right sampling for their testing.
Joe: Which gives an idea, I don’t understand the agency well enough. What could have been the catalyst or what kind of like is this, excuse my pedestrian example, is this like a CEO level thing? Or is this some Vice-President of something coming up and saying, “I have an idea,” and they got out the door? I mean how?
Michelle Lott: I’m former president of something for sure. One of the first things that Trump did was task the FDA that for every regulation. No, but he told FDA that for every regulation that they issued
Joe: They have to get rid of the two
Michelle Lott: He expect to get rid of two
Joe: But this doesn’t mean (indistinct), now its getting rid of it’s a change?
Michelle Lott: It’s a major regulatory change to lessen the burden from industry. But where they have chosen to do so in our opinions is some of the most high-risk devices.
Joe: Today we’re recording on the inauguration of Joseph R. Biden as the 46th president. In fact, it’s a minute away. Do you anticipate that what we’re talking about today will be reversed? And would it be an executive order that would direct FDA to? I mean, way out of my element here.
Michelle Lott: So what is going to happen next is that this proposed rule will be published in the “Federal Register” and then industry and the public have got, I can’t remember if it’s 60 or 90 days to submit their comments. Then HHS and FDA review the comments, and they decide which ones they are going to permanently exempt based off of the public comment.
Joe: Well, let me use my bully pulpit here to address the throngs of people that follow you Michelle, and by extension Ti. What should viewers of this video now do?
Michelle Lott: They should review the list in Table 6 and anything that they find concerning or shocking that, that type of device could be exempt from a 510(k) and effectively fight FDA oversight, for its safety and efficacy, need to submit a comment when this proposed rule is published in the “Federal Register”.
Joe: And given that most of my audience are device manufacturers, do you think that someone’s going to raise their hand and say, wait a minute, I want more regulation, for myself and this product that I am making?
Michelle Lott: I feel like that if they’re already making these products they’re going to want to protect their pathway to market because they did already do the work. And- and (indistinct).
Joe: Competitors come in with far less burden
Michelle Lott: And any of these, open-source or people that have never made medical devices before, that don’t understand all the testing or design requirements, because these products aren’t going to be exempt from design controls. But a lot of people that I’ve been talking to getting into this space, don’t even know what design controls are. So every Tom, Dick and Harry is trying to find a solution to COVID and COVID symptoms, but then we’re going to start killing people of things that could be worse than just riding COVID out with the technology that we have.
Joe: I know your calendar is overbooked but I dare close with people should call you about this if they what?
Michelle Lott: Care…
Joe: Okay that’s a big invitation. Hey everybody, call Michelle. No a bit more, who needs your help now with this?
Michelle Lott: If you want my help interpreting how you and your project are going to be impacted by this, call me. If you are concerned about the impact on the general public and the population that are going to get treated with these devices, call me. Let’s band together, let’s write letters, let’s help you with how your product is impacted. Maybe let’s you get your product to market before these changes are made, so you at least have that piece of paper that says, I had a 510 (k) before I had to” and you can show it to your customers in the hospital that says “Well of all your options right now, the FDA did actually look at my product to prove it’s safety and efficacy”.
Joe: I can recall nine years ago now I created the site called no2point3.com to rally signatures behind a motion. And we got some 11,000 signatures and God bless him John Eckberg over at Cook Medical recently retired said that that was a big thing and it really changed the course of things. I think he’s being generous. Is there any point in us writing a letter that people can download and send to their local someone or other? Does that make a difference?
Michelle Lott: That is actually a great idea. And it’s something that I have had in mind since I started my business to have an advocacy, for both industry to have a voice with FDA. But then now the voice is also to protect the general public. Some of this stuff just shouldn’t be on here.
Joe: Sounds like you’re hiring for that role now. Apply within… Michelle, Tianna Benson, thank you very much.
[Click here for the full transcript.]
Michelle explains what happened
Tianna: Ooh, please tell me.
Michelle Lott: So, it was just an algorithm that scavenged the database based off of the three criteria that they had for selecting products to down classify. They had to be on an EUA.
Michelle Lott: They had to have a history, they had to review the MAUDE history before the EUA, and then they reviewed the MAUDE history after the EUA. And then there was a numerical cutoff of the number of MAUDE events. And so, it was just a mathematical algorithm that went in and spit out a list of devices to put on that list to de-regulate.
Tianna: And so, the anti-virals are on there because there’s none of them are cleared. There’s no devices, right?
Michelle Lott: There are only three that have been cleared ever in the history of the product code and two of them aren’t even available in the United States right now.
Tianna: And so, there’s obviously no MAUDE events because they’re not available. And so, they get put in this low risk, oh no.
Michelle Lott: Even if they we’re available, there are only three that have been cleared and they wouldn’t hit that numerical cutoff anyway.
Michelle Lott: Same thing with pediatric masks. There are only a very few that had been cleared for pediatric indications. So they’re not gonna hit that number threshold of MAUDE events. It’s not that they’re not high risk devices. There was no person that looked at that list and mentally logically said, “Oh, no, that doesn’t make sense from a risk perspective” or hey, the ventilators for home use. It’s like, I wonder if the FDA actually reads that list later and they’re gonna go, what the what? We just down regulated something with major electrical safety and software concerns for home use. So we’re gonna let people who don’t know how to work medical equipment.
Tianna: They’ll use it at home?
Michelle Lott: Yeah, on their family member that is in a coma.
Tianna: Yeah, kind of horrible. It’s devastating. That makes so much more sense though because when you look at that list, my jaw hit the floor. I was like, how can they justify this, especially when they have lower risk devices that didn’t get down classified. And now, it makes perfect sense, but it’s because the testing stringency may make those devices unprofitable and so none get cleared. And so, now they think there’s no risk, but it just goes back to that idea that the FDA is doing their job and so there’s no reportable events. And now, they’re not gonna review these technologies and MAUDE events are gonna crop up everywhere. Because people cheap out on testing or don’t understand the requirements. They may sell for five years before they get an FDA inspection.
Michelle Lott: Good job, Padawan.
Michelle Lott: There you go.
Tianna: Crazy regulations.
Michelle Lott: Mystery solved.
Tianna: That is like, that’s nuts though. That’s that makes so much sense though. Like, from a peer data standpoint like not a human standpoint, but from a peer data numbers calculations, reduce burden standpoint it totally makes sense that you’re right they just swept the MAUDE databases. They swept before and after. And like, number of things met these criteria and then were like, “Ah, it’s fine.” ‘Cause nobody goes into those ’cause it’s so expensive and too hard to get the claims. And so, instead of re-evaluating what they need for the claim they just got rid of the evaluation altogether.
Michelle Lott: Yep, poof, no problem.
Tianna: 510(k) exempt! Go forth, manufacturers!
Michelle Lott: Yeah.
[Click here for the rest of the transcript.]
Michelle devises a plan: How you can help right now!
Joe: Very brained people did that and found?
Michelle Lott: That the criteria was set in such things like here, for example anti-viral, anti-bacterial masks are on the list. And one of the criteria was that the products could not have more than say x-number of MAUDE events. Say I think it’s let’s say 80 or 100.
Joe: Wow, I thought you said something in the single digits, but okay.
Michelle Lott: Do you know how many after all my ranting and raving about anti-viral, anti-bacterial masks? Do you know how many have been cleared in the history of the FDA?
Joe: Last I checked, 13.
Michelle Lott: Three.
Joe: But I checked wrong.
Michelle Lott: You probably looked the wrong product code. The product code is OUK, three. And two of those aren’t even available in the US anymore for whatever reason they either decided not to make them or all the manufacturing’s in China and they’re not shipping them to the United States.
Joe: By the way, is anything that was authorized through emergency use, are those still valid? ‘Cause I know that you taught me that once something happens, the EUA lapses and you need to 510(k) if you’re gonna continue to sell in the US. When is, that date hasn’t happened.
Michelle Lott: No, that’s at the determination of the president to determine if we’re still in a public health crisis or not. So the EUA, but we digress. So the reason why surgical masks so we don’t hit that MAUDE threshold is that there are only three that have ever been cleared, two of them are not being sold in the United States. So if there’s only three products ever, of course they’re not gonna hit a MAUDE criteria unless they did something really bad. So it doesn’t mean that the product is low risk and no longer needs FDA oversight.
Joe: It’s a ridiculous backwards way to figure stuff out. It’s like I just figured out how to ride a tricycle on a tightrope and I’m gonna be the first one to do it. And by definition since that’s not a risky behavior, there’s no recording of anyone falling to their death from a tricycle on a tightrope, we should be good.
Michelle Lott: Basically.
Joe: That’s their job at FDA, you’re saying.(laughing). All you people out there watching this, there’s hope for you.
Michelle Lott: And Ti pointed out when she was on your last MDG video, she mentioned this and that Rob Packard chimed in and said this is also what you get when somebody who’s new to the FDA barely–
Joe: Is in charge of running the show
Michelle Lott: Yeah
Joe: And that was, I think his comment was in the context of because they’re hiring so much.
Tianna: Or they can’t retain people.
Michelle Lott: Yeah, it’s the combination of can’t retain and have to hire.
Joe: ‘Cause it’s a misery to work there?
Michelle Lott: Yep, so this is the back at the Ranch moment. So Larry Stevens also from our MDG group reached out to me after he heard Ti mention this on the webinar you guys did. And he’s like, can you send me the link to that document? So I sent him the link to the draft, which is all I had seen come through my feeds. And so I had assumed because like a couple of days after we made that video, Biden cancelled everything that was in draft and said we’re gonna put everything in draft that hasn’t been published in the official record on hold. So I’m thinking, okay, all of those are moot now.
Larry scavenged around and found that this particular one actually managed to get published before Biden got sworn in and issued that. So it’s live which means that Biden put a pause on everything that did get published for 60 days for them to review it but it’s still out there for public comment because it is a legitimately published rule in the Federal Register for public commentary.
Joe: So do you believe the punchline is 53 days from now, there will be such a torrent of what are you guys nuts that it will go away?
Michelle Lott: I think that there is so much stuff that they have to go through that doesn’t make sense, that this could still fall through the cracks. And some of this could unfortunately become legitimate if enough people don’t comment on it.
Joe: So is this the part where we shake the viewer from the shoulders and say for the love of God, man! Will you please write your elected official and FDA and say what are you nuts?
Michelle Lott: Yep.
Joe: So that’s why Michelle and Ti are today introducing a template that people can download and send.
Michelle Lott: So we are working on that later today. You have to…So the comment process is online and you have to leave your comments one by one on the line items.
Joe: So there’s no reasonable way we can automate it for people so it’s a click and a send.
Michelle Lott: We’ll need to do it once ourselves and figure out if there is a way to do that, but I don’t think that there is ’cause you have to log in to the Federal Register. You could do it all anonymously.
Joe: Yeah, but still I who don’t have a record with the Federal Register would have to create an account first?
Michelle Lott: I don’t believe so.
Joe: Okay, how many would be critical number of correspondences that would make people even notice?
Michelle Lott: This isn’t a vote, so it’s no critical number. It’s that the FDA and HHS have to consider every single comment and respond to every single comment or groups of comments when they publish the final rule. So they have to think through every comment that somebody left.
Joe: So if my son were to log on and say, how come there’s no lemonade in this thing? They’d say, lemonade has nothing to do with it. They have to comment on everything, regardless of how whatever?
Michelle Lott: That’s my understanding of how it works because when you read a final rule, it starts with a proposed rule and then it goes through the comments that were received. And it adds a comment response.
Joe: That sounds ridiculous.
Michelle Lott: Yep, it’s why reading final rules are really, really hard because you gotta sort through half of the document to get to the final rule that ended up getting published.
Joe: Not to mention that the order of it could be just completely like, what? What did I just read about lemonade, huh?
Michelle Lott: Mm-hm, so that’s why it’s important if a lot of people get together and leave consistent comments, they have to address them. And then the more comments there are that are similar or related, the more consideration.
Joe: That it goes up to like, hey, boss, this is the 15th one that uses the identical language? Are you aware of any campaign that’s ever been run against guidance to get guidance reversed?
Michelle Lott: The medical device tax, for one.
Yeah, but there’s plenty and sometimes, this is my guidance documents, flounder for years and either just never make it to final or make it to final in a configuration that’s entirely different from the draft that was published.
Joe: Say that again
Michelle Lott: Draft guidance’s don’t ever get published as final guidance documents.
Joe: Because there’s so many comments? And they never got through it all?
Michelle Lott: Or just chose not to because there was too much dissension about it.
Joe: Okay, this would not be the case here because it’s already published.
Michelle Lott: This is proposed rule for comment. If you don’t comment, it goes to final as-is. If you comment, there is a chance that the FDA can change it and it goes to final with the consideration given to all the comments. So they change the final rule if the comments swayed their thinking.
Joe: I’m curious if this video in its entirely could be considered a comment and someone would have to watch it.
Michelle Lott: I highly doubt you can upload files to a federal government website.
Joe: Okay, I made a transcript of this whole damn call. Would they have to read the whole damn thing and comment on it?
Michelle Lott: I have never commented through the Federal Register before. And as soon as I figure out all the intricacies there, we can make another video, but it is an online process with the federal government. And what we’ve said here has no bearing because they want technical comments. The only thing we discussed was the anti-viral masks.
Tianna: They wanna know of those 83 exactly which ones you have a problem with.
Michelle Lott: And why
Tianna: And why and this weekend. So my family’s all in healthcare. My brother is a director of nursing and I actually was talking to him this weekend and people should care about this because you know what he told me that is terrifying? He says that with the new equipment their hospital is getting, they have seen ventilators, which are on this, stop working during transport, but they don’t have to report anything necessarily other than the failure because they don’t lose the patient because during transport, they always have a bag on them anyway. They have all of their safety controls to not lose a patient during that part, but a ventilator should never have to fail during transport.
Joe: If I understand you, an event is not a MAUDE event unless someone dies?
Michelle Lott: It’s up to each facility, each facility to decide when they report MAUDE events. From facility to facility, they may report that. They may not bother because this is the reason why they have two and three layers of fail-safes so that the patient doesn’t die. But it’s all up to the healthcare facility to determine what they report and when, which is another reason this is all over the place. During the EUA, again, they might not be bothering where they might have done so.
Tianna: Yeah, in the past. I will take my own personal experience with that. My mom leaves her house for work at 6:30 in the morning and she does not get home until 9 PM at night. These extra steps on an overtaxed healthcare system with no employees and people extremely sick with full ICUs, if a patient doesn’t die, they may not consider it a MAUDE event. They have fail-safes. They know what to do if equipment doesn’t work. And they revert to older styles. But that doesn’t mean that us as consumers should accept that on their behalf.
We’re in this industry to make safe devices, make the quality of life for people better and give people equipment that they can trust. And what’s actually happening is nurses and physicians are not trusting their equipment and they’re just going back to old standbys that they know work. So it’s a really tough time in hospitals right now. And they might not be seeing events like this, especially for ventilators because patients on a ventilator, the cause of death doesn’t necessarily have to be related to a ventilator failure. It’s hard to catch certain things. And then to have the extra burden of reporting every hiccup when you know a device shouldn’t be working there, it might not be getting caught.
Michelle Lott: Good Lord, they’ve got enough paperwork to fill out at the end of the shift already anyways.
Tianna: Yeah, they have a chart for every single one of those patients that they have to do.
Joe: So if I were to sum up the point of this episode of Back at the Ranch, it’s hey, everybody who watched this, I’m gonna give you a link and you need to be a responsible medical device citizen and let FDA know this is fucking nuts?
Tianna: And it should matter. It impacts your friends, it impacts your family, it impacts the general public, it should matter.
[Click here for the rest of the transcript.]
So, will you promote medical device safety today?
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