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News

The Food and Drug Administration (FDA) has announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

A Federal Register notice established the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019. According to FDA, to avoid delay in the review of your application, device manufacturers should pay the application fee before or at the time they submit an application to FDA. The fee they must pay is the fee that is in effect on the later of the date that the application is received by FDA or the date your fee payment is recognized by the U.S. Treasury.

For device manufacturers wanting to to pay a reduced small business fee, they must qualify as a small business before making your submission to FDA; if they do not qualify as a small business before making a submission to FDA, they must pay the higher standard fee. 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 manufacturer will pay in FY 2019, the company should not submit a Small Business Certification Request. For information on how the fees for FY 2019 were determined, the payment procedures to follow, and how to qualify for reduced small business fees. See the Federal Register notice here.

FY19 User Fees for Medical Device Submissions

The following table identifies the FY19 User Fees for Medical Device Submissions (in U.S. dollars).

Application Type

Standard Fee

Small Business Fee†

510(k)‡

10,953

2,738

513(g)

4,349

2,175

PMA, PDP, PMR, BLA

322,147

80,537

De Novo

classification request

96,644

24,161

panel-track supplement

241,610

60,403

180-day supplement

48,322

12,081

real-time supplement

22,550

5,638

BLA efficacy supplement

322,147

80,537

annual report

11,275

2,819

30-day notice

5,154

2,577

† For small businesses with an approved SBD.

‡ Note: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted by an FDA-accredited Third- Party Reviewer to the FDA.