On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees are for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.
The fee rates for FY 2018, is effective from October 1, 2017, through September 30, 2018. To avoid delay in the review of the sponsors application, the sponsor should pay the application fee before or at the time they submit their application to FDA. The standard FDA registration fees for larger companies is increasing by 33%, with the 510(k) application fee rising 125%. A comparison of the standard FY2017 MDUFA User Fees and FY2018 MDUFA User Fees is provided in below.
|Application Type||Standard Fee
(FY2017 MDUFA to FY2018 MDUFA)
|513(g) Request for Classification Information||$4,195||$3,166||33%|
|PMA, PDP, PMR, BLA||$310,764||$234,495||33%|
|BLA efficacy supplement||$310,764||$234,495||33%|
|PMA annual report||$10,877||$8,207||33%|
If a sponsor want to pay a reduced small business fee, the sponsor must qualify as a small business before making their submission to FDA; if the sponsor do not qualify as a small business before making their submission to FDA, they will have to pay the higher standard fee. The small business fees for most applications will see a 33% increases, with 13% increase for 510(k) user fees. A comparison of the Small Business FY2017 MDUFA User Fees and FY2018 MDUFA User Fees is provided in below.
|Application Type||Small Business Fee
|Small Business Fee
|(FY2017 MDUFA to FY2018 MDUFA)|
|513(g) Request for Classification Information||$2,098||$1,583||33%|
|PMA, PDP, PMR, BLA||$77,691||$58,624||33%|
|BLA efficacy supplement||$77,691||$58,624||33%|
|PMA annual report||$2,719||$2,052||33%|
|De novo Classification Request||23,307||–||–|
Each establishment that is registered (or is required to register) with the Secretary of Health and Human Services under section 510 of the FD&C Act (21 U.S.C. 360) because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device is required to pay the annual fee for establishment registration. The FD&C Act specifies the base fee for establishment registration for each year from FY 2018 through FY 2022; the base fee for an establishment registration in FY 2018 is $4,375. FDA Establishment Registration fees will rise 37% to $4,624 for the 2018 fiscal year from $3,382 in 2017. This fee is not discountable for small businesses.
Note: the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that a sponsor will pay in FY 2018, the sponsor should not submit a FY 2018 Small Business Qualification and Certification request.
See link for Federal Register notice: A Notice by the Food and Drug Administration on 08/29/2017