FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018

September 4, 2017

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 sponsor’s 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 FY2018 MDUFA	Standard Fee FY2017 MDUFA	Percent Increase (FY2017 MDUFA to FY2018 MDUFA)
510(k)	$10,566	$4,690	125%
513(g) Request for Classification Information	$4,195	$3,166	33%
PMA, PDP, PMR, BLA	$310,764	$234,495	33%
panel-track supplement	$233,073	$175,871	33%
180-day supplement	$46,615	$35,174	33%
real-time supplement	$21,753	$16,415	33%
BLA efficacy supplement	$310,764	$234,495	33%
PMA annual report	$10,877	$8,207	33%
30-day notice	$4,972	$3,752	33%
De  Novo	93,229	N/A	N/A

 

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 FY2018 MDUFA	Small Business Fee FY2017 MDUFA	(FY2017 MDUFA to FY2018 MDUFA)
510(k)	$2,642	$2,345	13%
513(g) Request for Classification Information	$2,098	$1,583	33%
PMA, PDP, PMR, BLA	$77,691	$58,624	33%
panel-track supplement	$58,268	$43,968	33%
180-day supplement	$11,654	$8,794	33%
real-time supplement	$5,438	$4,104	33%
BLA efficacy supplement	$77,691	$58,624	33%
PMA annual report	$2,719	$2,052	33%
30-day notice	$2,486	$1,876	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