켐론FDA코리아

Important Information on Medical Device User Fees for Fiscal Year 2018

(October 1, 2017 through September 30, 2018)

Dear Medical Device Establishment:

This letter provides information regarding medical device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which runs from October 1, 2017 through September 30, 2018.

Federal law (Medical Device User Fee Amendments of 2018, also known as MDUFA IV) authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device applications.

The FDA announced the FY18 user fees in an August 28, 2017 Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2018. The FDA requires user fees for the following types of medical device applications:

• premarket approval applications (PMAs),
• product development protocols (PDPs),
• premarket reports (PMRs),
• original biologics license applications (BLAs) for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research (CBER),
• some PMA and PDP supplements (e.g., panel-track, 180-day, real-time, 30-day notice),
• BLA efficacy supplements,
• premarket notifications (510(k)s),
• De Novo classification requests,
• requests for device classification information (513(g)s), and
• annual reports for PMAs, PDPs, and PMRs.

In addition, all medical device establishments are required to pay an annual establishment registration fee.

Effective in FY18, all requests for de novo classification are subject to a user fee.   

FY18 Fees for Establishment Registration
The annual establishment registration fee must be paid between October 1, 2017 and December 31, 2017.  For FY18, the registration fee for each establishment is $4,624 (in U.S. Dollars). All establishments that are involved in the production and distribution of medical devices intended for use in the United States are required to pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

The following educational resources on Device Advice and CDRH Learn provide more information on the process for initial and annual registration of your medical device establishment:

Device Advice (text-based information)

• Explanation of the establishment registration and device listing regulations

CDRH Learn (video-based training)

1. Regulatory Overview of Device Establishment Registration and Listing
2. FURLS Device Registration and Listing: Initial Registration

FY18 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Applications
In an effort to reduce the burden on small businesses, federal law offers a reduced rate for a business that meets the definition of a “small business,” which the law (738e (2)(A) of the Federal Food, Drug, and Cosmetic Act) defines as a business with $100 million or less in gross receipts or sales, including receipts or sales from all affiliates.

In addition, small businesses with gross receipts or sales of $30 million or less are eligible to have the fee waived for their first PMA, PDP, PMR or BLA.

In order to receive a small business fee waiver or reduction, the FDA must approve your application for a Small Business Determination (SBD).  For more information about the SBD Program, please review the FY 2018 Medical Device User Fee Small Business Qualification and Certification Guidance.

FY18 User Fees for Medical Device Applications
The following table identifies the FY18 User Fees for Applications (in US Dollars)

†  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 to the FDA by an FDA-accredited third-party reviewer.

The FY18 user fees apply to medical device applications received by the FDA on or after October 1, 2017.  If you wish to pay the FY17 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2017.

If you plan to submit an application to the FDA, the user fee payment must be received on or before the date you send the application. If the FDA receives an application without payment in full, it will consider the application incomplete and will not begin its review.