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Emergo Group prepares FDA 510(k) applications for a significant number of medical devices each year so we are quite familiar with what the FDA wants to see in each application and the pitfalls to avoid. The FDA does not provide a 510(k) template and they do not provide much information on what needs to be included in each section of the 510(k). As a result, many people who try to complete them find the process more difficult than they expected, leading to significant delays in getting their product cleared for sale. Also, the FDA 510(k) summary document provided online for public viewing is just a small fraction of a completed 510k application which can be hundreds of pages in length. See what must be included in a 510(k) submission.
For this reason, many consultants charge an open ended hourly rate to complete 510(k) applications, leaving you with the uncertainty of how much it will ultimately cost to obtain FDA clearance. Because Emergo Group has completed so many 510(k) applications, we can generally give you a very accurate estimate of what the final price will be to compile and submit the 510(k) to the US Food and Drug Administration.
At Emergo Group we take a two step approach to estimating the cost of preparing a 510(k) for you. First, we provide a detailed list of all FDA documents applicable to your device. Then we perform a gap assessment to determine whether your company has adequate documentation needed for the application. Many companies are unaware of the various guidance documents published by the FDA that specify testing and other requirements that must be conducted prior to submission. We carefully examine the FDA's requirements for your device and assess the documentation, clinical data and testing results you have now. After the gap analysis is complete you will receive a comprehensive document showing the areas the need to be addressed before you can realistically start the FDA 510(k) process.
After this gap analysis has been conducted and deficiency report delivered to you, the second step is the preparation of the 510(k). The price we charge depends on these factors:
After receiving the gap analysis document, you have the flexibility to select any one of the following courses of action:
We have found from our years of experience that many companies appreciate this two step approach because it ends up being more cost effective and leads to more successful outcomes.
Shown below are the user fees the FDA charges to a review 510(k) application. An annual Establishment Registration fee is also charged to all companies. The number in (brackets) is the discount given to "small businesses" with less than US$100,000,000 in annual sales. The fiscal year for the FDA starts on October 1 and ends September 30 each year. All prices in USD.
FDA 510(k) Application Review Fee
2012 – $4,049 ($2,024 for small businesses)
FDA Establishment Registration Fee
Payable once per year by every registered medical device company. No discount is provided to small businesses for the FDA Establishment Registration fee.
2012 – $2,029