This is the final post in a 3 part series on the FDA 510(k) process. In our first first post we talked about the basic 510(k) process and finding suitable predicate devices; in our second post, we provided an overview about how to determine which data will be needed for your submission. In this final post we will cover the actual submission process and what you can expect post-submission. We’ve combined all three posts into one easy to read white […]

In our first article, we talked about the overall FDA 510(k) clearance process, determining classification, identifying the right FDA product code, and finding suitable predicate devices. In this post, we will focus on how to determine which guidance documents and international standards may be applicable to your device. TIP: We’ve combined all three blog posts into a single PDF. Download it here. So you’ve done your homework and confirmed that your device must go through the 510(k) process. You know […]

If you’ve never prepared a medical device FDA premarket notification, commonly known as a 510(k) submission, figuring out where to begin can be daunting. The FDA website provides a goldmine of information but extracting those golden nuggets requires lots of digging. In this post, we’ll provide a primer on how to approach the FDA 510(k) approval process, explain how the process works, and talk more about predicate device research and identifying the right product code.   Already familiar with the […]