How much does a 510(k) cost? - FY 2024
Medical Device Academy Medical Device Academy
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 Published On Jul 29, 2023

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.

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