Comprehensive up-to-date news coverage by Chemron FDA Korea.
Important Information on Medical Device User Fees for Fiscal Year 2015 (October 1, 2014 through September 30, 2015)
Dear Medical Device Establishment:
This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2015 (FY15), which runs from October 1, 2014 through September 30, 2015.
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 Medical Device User Fee Amendments of 2012 (MDUFA III).
The FDA announced the FY15 user fees in a Federal Register notice published on July 30, 2014. User fees are required for the following types of medical device applications:
In addition, all medical device establishments are required to 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 FY15.
FY15 Fees for Establishment Registration
The annual establishment registration fee must be paid between October 1, 2014 and December 31, 2014. For FY15, the registration fee for each establishment is $3,646 (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.
We encourage you to review the informational resources to help you understand the process for registering your medical device establishment:
1. Explanation of the establishment registration and device listing regulations:
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
FY15 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 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 2015 Medical Device User Fee Small Business Qualification and Certification”.
FY15 User Fees for Applications
The following table identifies the FY15 User Fees for Applications.
FY15 User Fees (in U.S. Dollars)
|
application type |
standard fee |
small business fee† |
|
510(k)‡ |
$5,018 |
$2,509 |
|
513(g) |
$3,387 |
$1,694 |
|
PMA, PDP, PMR, BLA |
$250,895 |
$62,724 |
|
panel-track supplement |
$188,171 |
$47,043 |
|
180-day supplement |
$37,634 |
$9,409 |
|
real-time supplement |
$17,563 |
$4,391 |
|
BLA efficacy supplement |
$250,895 |
$62,724 |
|
annual report |
$8,781 |
$2,195 |
|
30-day notice |
$4,014 |
$2,007 |
† 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 FY15 user fees apply to medical device applications received by the FDA on or after October 1, 2014. If you wish to pay the FY14 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2014.
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 at: https://userfees.fda.gov/OA_HTML/furls.jsp?legalsel=2&ref.
