켐론FDA코리아

Important Information on Medical Device User Fees for Fiscal Year 2014:
(October 1, 2013 through September 30, 2014)

Dear Medical Device Establishment:  

This letter provides information regarding the medical device user fees, including fee rates and payment procedures, for Fiscal Year 2014 (FY14), which runs from October 1, 2013 through September 30, 2014.  

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

The FDA announced the FY14 user fees in a Federal Register notice published on August 2, 2013. This notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/html/2013-18623.htm. User fees are required for the following types of medical device applications:

• premarket approvals applications (PMAs)
• product development protocils (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 must pay an annual establishment registration fee.

Below we provide more information regarding the fees for establishment registration, small business waivers, and the user fees for applications for FY14.

  FY14 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2013 and December 31, 2013. For FY14, the registration fee for each establishment is $3,313 (U.S.). There are no waivers or reductions for small establishments, businesses, or groups - all establishments must pay the establishment registration fee. 
 

Please refer to the following resources for information regarding registration of medical device establishments:

• an explanation of how to register and list: click here
• an industry educational video (CDRH Learn) on the FDA requirements for medical device registration and listing : http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#reglist

FY14 Small Businesses; Fee Waiver and Fee Reduction Regarding Certain Medical Device Applications

In an effort to reduce the burden on small businesses, the FDA provides a reduced rate for businesses meeting 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.  

Small businesses with gross receipts or sales of $30 million or less are eligible to have the fee waived on 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 and reduction as applicable.  

More information on the SBD Program is described in the FDA Guidance “FY 2014 Medical Device User Fee Small Business Qualification and Certification,” found at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf  

FY14 User Fees for Applications

The following table identifies the FY14 User Fees for Applications.  

FY14 User Fees (in U.S. Dollars)

application type	standard fee	small business fee†
510(k)‡	$5,170	$2,585
513(g)	$3,490	$1,745
PMA, PDP, PMR, BLA	$258,520	$64,630
panel-track supplement	$193,890	$48,473
180-day supplement	$38,778	$9,695
real-time supplement	$18,096	$4,524
BLA efficacy supplement	$258,520	$64,630
annual report	$9,048	$2,262
30-day notice	$4,136	$2,068

† 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 on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR or BLA.  

The FY14 user fees apply to medical device applications received by the FDA on or after October 1, 2013. If you wish to pay the FY13 user fee for an application, both your application and your payment must be received prior to October 1, 2013.  

If you plan to submit an application to the FDA, the user fee payment must be received on or beforethe 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 at: https://userfees.fda.gov/OA_HTML/furls.jsp?legalsel=2&ref.