If you’re developing a medical device and looking for a contract manufacturer, the FDA’s Establishment Registration and Device Listing database is one of the best tools you can use. This video shows you exactly how to use the database to identify companies that are already registered to manufacture devices similar to yours.
By searching by product code or device name, you can quickly generate a list of manufacturers that have experience producing comparable products and are already registered with the FDA. This not only helps you narrow down potential partners but also gives you insight into their regulatory standing and areas of expertise.
Unlike general directories or marketing-driven platforms, this database reflects verified FDA information. It’s especially useful if you’re early in product development and want to find manufacturing partners who understand your device category and the associated compliance requirements.
Watch this short video to learn how to navigate the database and extract the information you need to build your supplier shortlist with confidence.
Need help getting started? Reach out to see how we can support your product development journey.
Useful links in this video:
Establishment Registration and Listing | FDA
Full Video Transcript:
This is going to be a quick little video to show you one of the really useful ways to use the FDA Establishment Registration and Device Listing website. There’s a lot of really useful information here, and I feel like this database is maybe a little bit underused.
So what we’re going to do is actually take an example of a product. Let’s say you find a product. This one happens to be a, what is it? It’s a IV set and you decide you want to make a product either the same or similar to this product and you’re looking for a contract manufacturer or where is this product made? What product code is this? There’s lots of different questions that can actually be answered with the establishment registration. Database. So first of all, you just need a label. Any product with a label, this is just generally chosen as a representative thing. This isn’t about sort of this product in particular, other than just using it as an example. But if you go ahead and look, this thing is by Baxter. It’s called a ClearLink DuoVent. So you can also start with the company. In this case, I kind of know that this isn’t going to be the best approach, but we’ll go ahead and look at it just because Baxter is the large company, they make a lot of things. Um, what you see is that they have 26. entries for Baxter, you could, click on each one of these and continue. There’s 7 listings, 12 listings there. There’s 149 listings here. Um, like I said, I don’t think this is the most direct approach, but if you were looking for something that was at a smaller company, you might get yourself there just with this. But in this case, given that Baxter is very large, what we’re going to actually try is the words DuoVent. Um, and one of the things you’re going to want to try is you may actually end up trying this kind of different ways. Maybe with and without the dash, you might try the clear link, you might try any other words you see on the label there. It’s not always a sort of direct response that it gives you, but let’s go ahead and try this and see what we get. Um, from here, this is better.
So now there’s eight results and you can see there’s eight here, eight here. So this is actually a smaller number that’s a little more manageable. And also right out of the gate, I’m seeing DuoVent interlink. So if I come back to my label, I see that this is a DuoVent clear link. So a lot of these are sort of good candidates for the thing that I have in the picture here. We don’t actually know which specific one is the thing in the picture, because at a company like Baxter, as you can tell, they’re making things in the U S, Puerto Rico, Dominican Republic, Malta, Costa Rica, et cetera. So, um, I’m not necessarily going to be able to tell you the exact factory that this thing came out of, but if I was trying to ask the question of, first of all, what product code is this? What class is this? Or what kind of companies could I use to make a product like this? Um, this is where I would go ahead and start. Um, what you’re going to see here is that they are, let’s see, Any one of these looks a good choice. Probably this one actually had the word clear link, lure activated, do event. Let’s try that one.
So you’re going to see that this is product code FPA. It’s a device class two and it’s regulation number 880, 5440. Um, so what I would go ahead and do is look at product code FPA. So this time, um, what you can do is you can read more about product code, FBA, FBA, and you can kind of make sure that sounds like it’s a good fit for you. You can actually also read more about the regulation. Take this number and you can plug it into a search and find it. In the actual description and go ahead and read it and make sure this sounds like it’s the right fit for the thing that you’re trying to make. Um, and then you go ahead over here, back to the establishment registration, but this time we’re going to put in product code FBA. So what we’ve learned already is the product code. It’s FBA. It’s device class two. What else we’ve learned from this is that, um, it requires a 510K. It is not GMP exempt. We already know a ton about this product just from looking at the label and putting it into this one database.
But let’s say I wanted to make something similar. I could say, what kind of manufacturer am I looking for? Product code. FBA. So we already know that. And this time we’re going to actually choose contract manufacturer as the establishment type. And the reason here is that if I were going to be a virtual manufacturer here in the U S and I wanted to go find a contract manufacturer that could make me a set of IV lines, that’s what I would look for. So then we’re going to click search. And what we’re going to find is that there’s actually 98 results for contract manufacturers that make this product code. And what you find right away is, um, you know, a bunch of these contract manufacturers are making the exact same thing. You again may not know which one is exactly the Baxter, that’s not the intention of this exercise. This exercise is to say, if I wanted to make a product like this, could I find a manufacturer to do it? And the answer is yes. So here’s a whole list of 98 different manufacturers that are at least candidates for making your product. Um, so you can obviously see where they’re located. You can see, um, other things about them. You might prefer that one of them actually be a sterilizer as well. So something like this might be the kind of company you want to start talking to first if it’s important to you that they can contract manufacture and contract sterilize. Um, let’s see if we actually already took this list of all 98 of them. Oh, real quick note. You can actually go here and see all a hundred of them, um, if you want to. There’s quite a few options depending on where you are located and what your preferences are you know, there may be some reason you have a regional preference and everything is listed here. So I already took this list and I just exported it into Excel, which again is, helpful. I could sort, filter, you know, I could have a task of contacting every one of these companies and getting their information on, contract manufacturing services. Um, what else you get from this list is actually also a little bit about their contact information. Let’s look at this company. This is the kind of company I would go ahead and contact if I was looking for a contract manufacturer, ideally in Mexico. And then they have information here, so you can find their kind of official name, address, things like that, that you could then use to, of course, contact this company, if you were interested in getting a quote for, contract manufacturing, lead times, anything like that. So, just with this one label for the product that we actually had in our hand, we were able to find the product code, the classification, the applicable regulations, and some contract manufacturers that could make a product like this for us. So, that’s it. That’s super useful and really the power of the Establishment Registration and Device Listing Database, which is a database I rely on frequently.