Welcome to part 1 of a series of posts relating to the process for receiving approval for a 510K medical device design. We are a contract manufacturer and we recently had a client require that we have FDA 510K clearance for manufacturing their product. The product that we are planning to apply for is a class II medical device and has been in existence since the early 1900s. There are hundreds if not thousands of predicate examples of this product.
We wanted to create a series of posts which relate to this process since it seems like there aren’t too many good 3rd party sources which want to help manufacturers through this process and the FDA documentation can be overwhelming.
Find out CFR section and Class
We started out by identifying the CFR section and class our device fit into. The difference between classes is immense. Class I products often do not need 510K approval in order to be marketed. Class II products are usually based on predicate devices and must prove that they are similar. Class II products take on average about 6 months for approval. Class III products usually don’t have predicate devices and take a long time to get to market. The product that we are pursuing is Class II and we are crossing our fingers that this process only takes 6 months since we are complete novices.
I was able to get to the following page by searching fda.gov for the type of product I was looking for, which in our case is a k-wire:
Figure out which type of 510K Application is needed
Next we identified which type of 510K application was needed (Traditional, Abbreviated or Specialty). We were hoping for abbreviated, it sounded like less work. Unfortunately, we needed to do traditional. We originally started our trying to read the different requirements for each type of application and found ourselves down a rabbit hole. The easiest way to find out which application is needed is to search the FDA website for predicated devices with the same CFR section number and it says what type of application they used. Since we are basing our application on a predicate device, I am looking to re-use as much work as I can.
I was able to get to find out the type of application I needed to use by typing the “k number” of a an existing k-wire approval and looking at the information:
That is it for today, now I know that I am going to need to do a traditional FDA 510K application and that it is a Class II device. For my next post I will take you through the initial stages of writing a traditional 510K application.