Hello everyone and welcome back to MedTech Compliance Chronicles. Last week we took a pretty detailed look into how the US FDA classifies medical devices and what they look for in making classification determinations.
This week, we will go more into what you, as the manufacturer, are going to do in order to determine the class of your medical device before you make a submission to the FDA. Technically, you can forego this process as a whole and submit a request for classification under section 513(g) of the Food, Drug and Cosmetics Act. Be aware, if you go the 513(g) route it does come with its own set of fees and leaves your business now waiting on a third party. In any case, what you (or the FDA if you choose 513(g)) are ultimately going to do is search the FDA’s database on currently marketed devices for devices that are similar to yours. Once you’ve found such a device(s), you will try to prove that your device is ‘substantially equivalent’ to that device. Once, and if, you can prove substantial equivalence, your device class will be the same as the ‘predicate’ device (the device to which substantial equivalence is demonstrated). In this post, we spend some time on how to search for currently marketed devices and determine their classification and then get into what the FDA is looking for in order to consider a device substantially equivalent to a currently marketed device.
Searching for Predicate Devices
In order to do the actual searching you will need to go to the FDA’s Product Classification Database. There you will be able to search your device by description. The description you use should be a very general description of what the device is, for example “mouthguard.” If something too general returns too many results you can get more specific in your description but remember to consider different devices when first searching for a predicate device. Once you have a few good options that you believe are similar to your device, examine the ‘product code’ for each device. If all the devices you believe your device is substantially equivalent to have the same product code, that will likely be your device’s product code. If the codes differ, take note of all of them.
The next thing you will need to do is search the product code(s) that you found in the same database you initially searched by description. The results of the search will basically give you all the information you need to know how to proceed, most immediately useful being the device class and submission type. However, in order for this information to be correct for your device, you must prove substantial equivalence to a device already marketed under the same general description and product code. With the submission type, you can search the respective databases (510(k) or PMA) to find currently marketed devices under the same product code. Now let's get into what you will need to be able to provide in order to claim substantial equivalence.
Substantial Equivalence
The two primary points the FDA looks at when determining substantial equivalence are: do they have the same intended use? And do they have the same technological characteristics? The latter is not always a strict rule. Devices with different technological characteristics can still be determined substantially equivalent as long as they have the same risks associated with them.
Unfortunately, at this point you will need to do a little bit of research on your predicate devices to make further determinations of substantial equivalence. The product code search results do specify whether or not consensus standards exist for this device type and, if they do, you will need to include that standard(s) in your research. We will go into details about what specific types of documents you will need to provide to prove substantial equivalence in a later post about 510(k) submissions. For now, we have determined the class we believe the device is in and identified any consensus standards that exist for it.
Conclusion
The determination of device class and applicable standards give information on what types of ‘requirements’ your organization will be held to. Knowing these requirements will be paramount in setting up your organization’s quality management system (QMS). You should set up your QMS before you make your submissions as you must clear a QMS audit before the device can be marketed anyway. As such, next week we will get started on the long journey of setting up a QMS!
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