켐론FDA코리아

Important Information on Medical Device User Fees for Fiscal Year 2017

(October 1, 2016 through September 30, 2017)

Dear Medical Device Establishment:

This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2017 (FY17), which runs from October 1, 2016 through September 30, 2017.

Federal Law (Food and Drug Administration Safety and Innovation Act – FDASIA) authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device applications. The user fee requirements are described in the Medical Device User Fee Amendments of 2012 (MDUFA III).

The FDA announced the FY17 user fees in the Federal Register titled Medical Device User Fee Rates for Fiscal Year 2017 published on July 29, 2016.  User fees are required 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)

• requests for device classification information (513(g)s)

• annual reports for PMAs, PDPs, and PMRs.

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

FY17 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2016 and December 31, 2016.  For FY17, the registration fee for each establishment is $3,382 (in U.S. Dollars). All establishments 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.    Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website

3.    FURLS Device Registration and Listing: Annual Registration

4.    FURLS Device Registration and Listing: Initial Registration

FY17 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Applications In an effort to reduce the burden on small businesses, the FDA provides a reduced rate for a business that meets the definition of a “small business.” A small business is defined 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.

Any business, regardless of location, may apply to the FDA for a small business determination (SBD), which grants a small business fee waiver or reduction as applicable. In order to apply a small business fee waiver or reduction as applicable, FDA must first approve you as a Small Business.  For more information about the SBD Program, please review the FY 2017 Medical Device User Fee Small Business Qualification and Certification Guidance.

FY17 User Fees for Medical Device Applications The following table identifies the FY17 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 FY17 user fees apply to medical device applications received by the FDA on or after October 1, 2016.  If you wish to pay the FY16 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2016.

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.