The US Food and Drug Administration charges a fee to review your 510k application.
FDA 510(k) Application Review Fee (prices in US dollars)
2013 – $4,960 ($2,480 for small businesses)
FDA classifies as “small businesses” companies with less than US $100,000,000 in annual sales. If fees owed are not paid, FDA will consider your 510k submission incomplete and will not accept it.
All companies are also required to pay an annual Establishment Registration Fee. The fiscal year for the FDA starts on October 1 and ends September 30 each year and the Establishment Registration Fee is payable once per year by every registered medical device company.
FDA Establishment Registration and Medical Device Listing Fee (prices in US dollars)
- 2013 – $2,575
- 2014 – $3,200
- 2015 – $3,750
- 2016 – $3,872
- 2017 – $3,872
Most medical device companies that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those medical devices. No discounts are provided to small businesses for the FDA Establishment Registration and Device Listing Fee.
ISOplan USA can help you arrange payments for both the FDA 510(k) Application Review Fee and the FDA Establishment Registration and Medical Device Listing Fee.