Grapefruit USA Inc (GPFT)

[3RunHomer]

There was some discussion yesterday about FDA cost to review the application. I found some numbers and they are not as expensive as I had imagined.

The FDA also charges a fee to review your 510(k) application.
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
2010 – $4007 ($2004 for small businesses)
2011 – $4348 ($2174 for small businesses)
2012 – $4717 ($2359 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.
2010 – $2008
2011 – $2179
2012 – $2364

FDA 510K Fees