Medical Devices User Fees for Fiscal Year 2017 (August 2016)The Food and Drug Administration (FDA) is introducing new rates for certain medical device submissions for the 2017 fiscal year under the Food, Drug, and Cosmetic (FD&C) Act. Fee updates for the 2017 fiscal year include fees for medical device premarket approval applications and notifications, fees associated with requests for information and supplement submissions, and annual registration and listing fees for establishments which manufacture or distribute medical devices. In some cases, applicants may receive fee waivers and small businesses may pay a reduced fee.
|Fee Type||Standard Fee||Small Business Fee|
|Premarket Application (PMA)||$234,495||$58,624|
|510(k) premarket notification submission||$4,690||$2,345|
|513(g) Request for Classification Information||$3,166||$1,583|
|Annual Fee for Periodic Reporting (Class III)||$8,207||$2,052|
|Annual Establishment Registration||$3,382||$3,382|
|Medical Device User Fee Rates for Fiscal Year 2017|