How much does an FDA 510(k) submission cost?

How much does a 510(k) cost is the most common question I receive from customers. There are three parts to the costs of a 510(k):
1 - Testing Costs
2 - Submission Preparation
3 - FDA User Fees
➤ https://medicaldeviceacademy.com/fda-...

We cover each of these costs in the video, but you can save $16K if you apply for small business status.
➤ https://medicaldeviceacademy.com/smal...

Medical Device Academy has the pricing of our consulting services posted on our website for you to download:
➤ https://medicaldeviceacademy.com/wp-c...

The most expensive cost will be your testing.

Time Stamps:
0:00 Intro
0:26 FDA 510(k) User Fee
2:00 Other FDA User Fees
3:20 Don't Pay Registration Until After you Receive 510(k)
3:34 Overall 510(k) Costs
7:13 Small Business Qualification
8:41 Testing Costs
12:55 Contact Us