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Important Information on Medical Device User Fees for Fiscal Year 2019 (October 1, 2018 through September 30, 2019)

August 1, 2018

Dear Medical Device Stakeholder:

This letter provides you with information about the annual establishment registration fees, small business designation and fees, and medical device user fees for Fiscal Year 2019 (FY19), which runs from October 1, 2018, through September 30, 2019.

Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device submissions and establishment registration. On July 30, 2018, FDA announced the FY19 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2019. User fees are required for the following types of medical device submissions:

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

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

FY19 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2018, and December 31, 2018.. For FY19, the registration fee for each establishment is $4,884 (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 FDA’s 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 education)
Establishment Registration and Device Listing: Program Description

CDRH Learn (video-based education)
1. Device Establishment Registration and Listing: Overview
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

FY19 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Submissions
To reduce the financial burden on small businesses, the FDA reduces the user fee for a qualified small business. “Small business” is defined as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR or BLA.

To receive the small business discount, you must be certified by the FDA as a small business. For information on how to apply for small business certification, please review the Medical Device User Fee Small Business Qualification and Certification Guidance. The FDA must first certify you as a small business before you may apply a small business fee reduction or waiver to a submission with a user fee.

Any business, regardless of location, may apply to be certified as a small business.

Change to Small Business Process Effective for FY19:  
The Medical Device Small Business Guidance and associated forms are now applicable for all future fiscal years. We will no longer publish an annual guidance that expires at the end of the fiscal year.

When filling out the required forms ( Form FDA 3602 and Form FDA 3602A), please identify the fiscal year for your request at the top of the form.

We will begin accepting Small Business Requests for FY19 starting on August 1, 2018. FY19 Small Business status will be from time of approval through September 30, 2019.

More information about the Small Business Program may be found at Device Advice:
Reduced Medical Device User Fees: Small Business Determination (SBD) Program

FY19 User Fees for Medical Device Submissions
The following table identifies the FY19 User Fees for Medical Device Submissions (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 by an FDA-accredited Third- Party Reviewer to the FDA.

The FY19 user fees apply to medical device submissions received by the FDA on or after October 1, 2018. If you wish to pay the FY18 user fee for a submission, both your submission and your user fee payment must be received prior to October 1, 2018.

If you plan to submit a submission to the FDA, the user fee payment must be received on or before the date you send the submission. The FDA will begin its review of a submission only after we receive your full payment.

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 website. For additional information or instructions regarding how to submit the fee, please visit the Device Facility User Fee website.