The 510(k), also known as “premarket notification” , is one of the most common procedures for the authorization of medical devices in the USA. The concept is based on demonstrating equivalence with a predicate device (comparator device). But the same mistakes, which can result in the entire 510(k) authorization failing, are made time and again. It doesn't have to be this way.
This article will explain the five most common mistakes made when submitting a 510(k) and how they can be avoided.
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Unlike in EU law, where devices are classified on a case-by-case basis by following rules, there are predefined fixed codes for specific device classes. Therefore, manufacturers “only” have to identify the right code for their device from more than 1700 different codes.
The product code provides valuable information for the submission, including:
But mistakes are often made when trying to identify the right product code.
Timing is critical: You should determine the product code when the intended use of your product has been established.
The FDA describes the term “intended use” as follows:
intended use means the general purpose of the device or its function, and encompasses the indications for use.
We use the term “intended use” in this sense in the rest of the document.
The next steps are:
The Johner Institute will be happy to help you if you have any questions about the 510(k) procedure. Our experts will, of course, also be happy to answer any questions you may have about product codes. Contact us!
The FDA also offers assistance. The website Classify Your Medical Device describes different ways of working out the classification and therefore the product code of your device.
One option is, for example:
If there is anything you are not sure about, you can also contact the FDA.
Above all, a 513(g) request prevents a device from being submitted with an incorrect code by mistake. However, the FDA charges a fee for these requests.
Information on how to submit a 513(g) can be found in the following guidance document: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
The FDA has established specific requirements for numerous devices that must be complied with and demonstrated in the 510(k). Not knowing these requirements or failure to fully comply with them often leads to questions from the FDA. For example:
First of all, manufacturers should check whether there are device-specific requirements that have to be taken into account in their premarket notification. Manufacturers can identify these requirements by:
A 510(k) is based on the concept of “substantial equivalence” (SE). This means that manufacturers demonstrate that their device is just as safe or safer than an equivalent device already legally available on the market. A device is equivalent (SE) if it has:
If the device has the same intended use but different technological characteristics, it must be demonstrated through device tests or clinical or scientific data that:
The substantial equivalence discussion is therefore an important part of a premarket notification. The discussion should include the new device’s characteristics with an explanation from the manufacturer as to how they are comparable to the equivalent device.
Common mistakes include:
These mistakes can be avoided by:
The predicate device must be similar to your device with regard to its intended use and its technological characteristics. You can have more than one predicate device, but the FDA recommends defining a primary predicate device.
The following questions will help you identify the right predicate device:
You can also use the decision tree in Appendix A of FDA guidance document The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] for reference.
Formal errors are definitely one of the most common problems with applications of all types. That's why the FDA reviews the formal requirements in two steps before the 510(k) is even submitted to a technical reviewer:
The most common formal errors in 510(k)s include:
The tools provided by the FDA are also helpful:
The FDA itself offers extensive guidance for 510(k)s. Anyone who doesn’t pay (enough) attention to these guidance documents often makes the following mistakes:
The FDA has published guidance documents on what content is required in a premarket notification. These include lists of which documents have to be submitted. They should, therefore, be taken into account even in the development stage. This ensures that all the documents required are created.
The following documents are particularly worth paying attention to:
Numerous other guidance documents on a wide range of topics are available in the FDA database.
510(k)s, also known as premarket notifications, are the specified pathway to the US market for a lot of devices. However, you must avoid the most common mistakes. In summary, you should pay attention to the following: