This is the final post in our three-part series on the FDA 510(k) process. In our 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.
TIP: We’ve combined all three blog posts into a single PDF. Download it here.… » Read more
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 the classification, three-letter product code, and the regulation number, and you’ve done an exhaustive review of summary documents for competing devices.… » Read more
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 basic 510(k) process?
Skip to our second post, which discusses guidance documents and data needed for submissions.… » Read more
In 2018, FDA cleared 3,000+ medical devices via the 510(k) process. An overwhelming majority of those devices (82%) went through the Traditional 510(k) process. Only 60 (less than 2%) went through the alluring “Abbreviated 510(k)” process. Why? Well, frankly there is very little that is “abbreviated” about that process, as it still requires the submitter to demonstrate “substantial equivalence” to a suitable predicate device.
Now, however, FDA has finally done something to provide relief from this requirement – it released a new guidance in January 2019 that supports the agency’s regulatory mandate to offer the “least burdensome approach” to manufacturers.… » Read more