What to Expect After You Submit Your 510(k) Application to FDA

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 […]

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Digging In: Do You Have the Data Needed to Support a Successful FDA 510(k) Submission?

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 […]

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The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval

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 […]

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New FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.

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 […]

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