켐론FDA코리아

Important Information on Medical Device User Fees for Fiscal Year 2016

(October 1, 2015 through September 30, 2016)

Dear Medical Device Establishment:

This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2016 (FY16), which runs from October 1, 2015 through September 30, 2016.

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 FY16 user fees in the Federal Register titled Medical Device User Fee Rates for Fiscal Year 2016 published on August 3, 2015. 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]
• 513(g)s (requests for device classification information)
• annual reports for PMAs, PDPs, and PMRs.

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

FY16 Fees for Establishment Registration
The annual establishment registration fee must be paid between October 1, 2015 and December 31, 2015. For FY16, the registration fee for each establishment is $3,845 (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 resources provide more information on the process for annual registration renewal of your medical device establishment:

1. Explanation of the establishment registration and device listing regulations:Device Registration and Listing

2. CDRH Learn Video: Overview of Device Establishment Registration and Listing

3. CDRH Learn Video: Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website

4. CDRH Learn Video: FURLS Device Registration and Listing Module Annual Registration

FY16 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. For more information about the SBD Program, please review the FY 2016 Medical Device User Fee Small Business Qualification and Certification Guidance.

FY16 User Fees for Applications
The following table identifies the FY16 User Fees for Applications.

FY16 User Fees (in U.S. 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 FY16 user fees apply to medical device applications received by the FDA on or after October 1, 2015.  If you wish to pay the FY15 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2015.

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.

Please do not send your user fee payment to the FDA with your application. You must submit your user fee separately through the Device Facility User Fee (DFUF) website. For additional information or instructions regarding how to submit the fee, please visit the DFUF website.