We follow two steps:
Step 1 is to evaluate your device and your technical data.
If you have basic technical data available, you can start right now by paying via credit card and proceeding into the portal secure area, where you will answer questions and upload documents. We will evaluate and provide a comprehensive regulatory report that includes gap analysis and related regulatory information. We will quote you on step 2 as well. Please refer to FAQ page for further details.
Step 2 is the actual preparation of the 510k. If you decide to move forward with the 510k submission, your additional cost should be between $3,500 and $8,500 (unless the device is DeNovo or the submission includes clinical studies).
So, other than FDA review fees, your total investment would be between $5,000 and $10,000 to cover steps 1 and 2.
We are committed to your success, and will follow diligently with FDA to obtain your clearance letter.