Very few days go by without someone asking me to explain the differences between FDA submission types.
This most often comes up when a client thinks their product can be classified as 510(k) exempt. Or requires just a “simple” 510(k) submission.
When I explain that based on their product claims and intended use, they actually have to do a PMA, chaos ensues.
Here are some key things to remember when choosing the right FDA submission type for your product:
The standard 510(k) submission is based on demonstrating substantial equivalence to a predicate device. You will compile anywhere between 500 and 1000 pages of documentation, on average, and the small business submission fee will be roughly $3,100.
This route will require about 100 – 150 days for FDA review (but likely more) and will result in Market Clearance for your device.
The de novo submission can be complicated. Without substantial equivalence, a de novo submission helps the FDA classify your device. The amount of documentation varies, and the current review time is between 180 and 300 days (Feb 2021).
If your de novo submission is approved, the fee will be about $27,000 and you will be granted Market Clearance. If the de novo is denied, then you have to go the PMA route.
The PMA submission is the most time-consuming and the most costly. You have to provide valid scientific evidence of safety and efficacy, which can add up to about 30 binders’ worth of documentation. A PMA submission is expensive (about $91,000) and time consuming (250 to 300 days to review as of Feb 2021) and will result in a Premarket Approval for your device.
Editor’s Note: FDA review times have changed significantly. The timelines listed represent the current 𝘢𝘯𝘵𝘪𝘤𝘪𝘱𝘢𝘵𝘦𝘥 review times for the various FDA submission types, which are very different from the traditional (somewhat shorter) review times. And the timelines are still subject to change at any moment based on, well, COVID. Or the whim of the FDA reviewer. 😁
Link to the original post: https://www.linkedin.com/posts/michellelottraqa_medicaldevices-fda-regulatory-activity-6767457369338204160-XE5Z
Check out my website for more cool regulatory-speak: https://leanraqa.com/