The biggest misconception regulatory professionals have about the FDA 510(k) program, according to Mark DuVal
The 510(k) program is the most common pathway through which medical devices make their way to market in the US.
For devices that can demonstrate “substantial equivalence” to a device that is already on the market, this premarket submission to the US Food and Drug Administration (FDA) is a necessary step to market the device in the US. But that doesn’t make the 501(k) program a simple subject.
RAPS spoke with Mark DuVal, a RAPS member who serves as the president and CEO of DuVal & Associates, about the 510(k) program, the common difficulties and misconceptions regulatory professionals have with it, his upcoming RAPS workshop on the subject and more. This conversation has been lightly edited for clarity.
What is the 510(k) program and what do regulatory professionals need to know about it?
Well, let me explain to you by way of showing the continuum of how devices get to the marketplace:
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There are Class I exempt devices that don't have to come to the FDA. They just register their establishment, list their device, and they can go to market.
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At the other end of the spectrum, there's a Premarket Approval application (PMA), which is a Class III high-risk device, and you have to do a lot of clinical trials. It's a lot of expense and then you get approved by the FDA.
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In between, the 510(k), is devoted to products that are moderate risk. And you have to establish three definitional elements. Basically, you're showing sameness to a product starting on the market called a predicate. So, you must show the same intended use, same technological characteristics, and if those technological characteristics differ—which they're allowed to—then you must show that they don't raise different questions of safety and effectiveness.
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So those are the three essential pathways. The other one is the De Novo, which says, “I believe I'm a Class II moderate-risk device, but I don't have a predicate, so don't put me in a Class III high-risk category. I want to stay Class II, a moderate risk.” And then you can petition the agency under the De Novo regulations to do that.
What are some common mistakes regulatory professionals make — or misconceptions they might have — related to the 510(k) program?
Let me start with the misconceptions. For example: “I can't push back on the FDA. I have to be so deferential to them that I can't really argue my case effectively and persuasively.”
Really, regulatory affairs professionals shouldn't be as deferential to the FDA. They're not our enemy, nor are they our friend. They are our industry colleagues. And we have to have respectful diplomatic discussions with one another to achieve the end of getting safe and effective products to the marketplace.
The biggest mistake I think that regulatory affairs professionals make in their submissions is they really don't argue their case. When biomedical engineers put together a submission, they think of it as an evidentiary document. They put together all this great evidence and they're good at doing it. They put it in the format the FDA wants, and they submit it. But sometimes that falls short. We think of the 510(k) as an advocacy document—with evidence. We want to tell the story for this device and where it fits in the continuum of devices that are in the market, why it's similar to the device we're claiming as a predicate, etc. But the key is to persuade FDA to our position.
Why is navigating the 510(k) pathway like being on the TV show Survivor?
I used to watch Survivor all the time. Now I don’t as much anymore so I’m getting a little dated, but Survivor is about being out there somewhere in the wilderness, on a deserted island, and you’re just trying to survive. And you need to have enough understanding of, “What will it take to survive?”
We’re trying to give them the essential elements, the things that they might get, like on the TV show, to become a survivor and win. How do you run the gamut, getting through FDA successfully on behalf of your company?
What will someone learn by coming to RAPS’ Survivor: The FDA 510(k) Program Edition workshop?
If you want to get some very practical insights and even insider information—because we have former FDA reviewers and we have Ken Skodacek, who’s the FDA deputy ombudsman—you're going to get some real insight as to how to take your submission to the FDA, and what are the political dynamics that you're going through, and how do you effectively navigate this agency in the framework of a 510(k) program and hold FDA to the commitments it makes in its own guidance documents?
The idea is that we all want to get products to the marketplace that are both beneficial for patients and safe, and it's a balance. And FDA tends to sometimes overemphasize the risk side at the expense of the benefit side. Our job is to make them look at it fairly and hopefully get these products on the marketplace where physicians can use them, and patients can benefit from them.
While the regulations haven’t changed, FDA’s expectations have. Can you explain why that happened and why regulatory professionals should care?
The FDA is always going to escalate data requirements. That's the inevitable evolution of any governmental agency. They have this little fiefdom they've created, and they're increasingly getting more complex and sometimes less responsive. They try hard. They're just people. They're trying to do their job. They're devoted to what they're doing. But we're overcomplicating things sometimes. My job is just to bring them back to their moorings from their starting place and say, "Look, we're mindlessly escalating data requirements,” for example. Were we too cautiously interpreting, “What is the same intended use? Or does it have a different technological characteristic?” And so, we're trying to liberate them a little bit. And we do that, frankly, by bringing back to the statute, the regulations, and their own guidance documents, which are literally their own written word that they frequently will deviate from. So, we just help them and try and persuade them to our client's position.
You have FDA presenters join you at this RAPS’ Survivor: The FDA 510(k) Program Edition workshop. How do you maintain those relationships while arguing against the agency?
I am very respectful of the agency. I love working with them. All our staff, all of the folks who work at our firm, we that's what we do for a living. Our stock and trade are our relationships there. So, we can't blow it. But any relationship is forged out of good and bad times. Sometimes you're pushing pretty hard and sometimes it goes pretty smoothly for both sides.
I love having the ex-reviewers who are now in industry because they really see it from a different vantage point. One of our reviewers was in today and he was just fatigued, kind of doing battle with the agency and seeing a completely different side of the world now. And he loved working there. He has great friends and colleagues there, but now he has a job to do on behalf of a company. And he thinks there are times the agency can be unreasonable. There are times they're completely reasonable. And they're not monolithic. The agency is just like any big company, right? A lot of different people with a lot of different personalities. You get the crabby types, you get the types who are super easy to work with and everywhere in between.