CORRECTION: Important Information on Medical Device User Fees for Fiscal Year 2018

CORRECTION:  Important Information on Medical Device User Fees for Fiscal Year 2018

(October 1, 2017 through September 30, 2018)

Dear Medical Device Establishment:

This letter corrects the dollar amounts listed in the letter sent August 28, 2017.

This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2018 (FY18), which runs from October 1, 2017 through September 30, 2018.

Federal Law (Medical Device User Fee Amendments of 2017, also known as MDUFA IV) authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device applications.

The FDA announced the FY18 user fees in an August 28, 2017 Federal Register Notice titled Medical Device User Fee Rates for Fiscal Year 2018.  The FDA requires user fees 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),
• De Novo classification requests,
• requests for device classification information (513(g)s), and
• annual reports for PMAs, PDPs, and PMRs.

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

Effective in FY 18, all requests for de novo classification are subject to a user fee.   

FY18 Fees for Establishment Registration The annual establishment registration fee must be paid between October 1, 2017 and December 31, 2017.  For FY18, the registration fee for each establishment is $4,624 (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

FY18 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Applications In an effort to reduce the burden on small businesses, federal law provides a reduced rate for a business that meets the definition of a “small business.” which the law (738e(2)(A) of the Federal Food, Drug, and Cosmetic Act) defines 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.

In order to receive a small business fee waiver or reduction, the FDA must first approve you as a Small Business through the Small Business Determination (SBD) Program.  For more information about the SBD Program, please review the FY 2018 Medical Device User Fee Small Business Qualification and Certification Guidance.

FY18 User Fees for Medical Device Applications The following table identifies the FY18 User Fees for Applications (in US Dollars)

application type	standard fee	small business fee†
510(k)‡	10,566	2,642
513(g)	4,195	2,098
de novo classification	93,229	23,307
PMA, PDP, PMR, BLA	310,764	77,691
panel-track supplement	233,073	58,268
180-day supplement	46,615	11,654
real-time supplement	21,753	5,438
BLA efficacy supplement	310,764	77,691
annual report	10,877	2,719
30-day notice	4,972	2,486

†  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 FY18 user fees apply to medical device applications received by the FDA on or after October 1, 2017.  If you wish to pay the FY17 user fee for an application, both your application and your user fee payment must be received prior to October 1, 2017.

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.

For More Information If you have questions regarding medical device user fees, regulatory requirements or other related information, please contact the FDA Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health (CDRH). Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. - 12:30 p.m. and 1:00 p.m. - 4:30 p.m. Eastern Time or by email at DICE@fda.hhs.gov.  Please also refer to the DICE website at www.fda.gov/DICE.  

Questions regarding products regulated by the Center for Biologics Evaluation and Research (CBER) should be directed to the FDA Office of Communication, Outreach and Development (OCOD), Manufacturers Assistance and Technical Training (MATT) Branch. Contact CBER MATT at (800) 835-4709 or (240) 402-8010 or by email at industry.biologics@fda.hhs.gov.

More information about medical device user fees and MDUFA IV may be found at the FDA MDUFA webpage. On this page, you may also sign up to receive updates each time FDA updates MDUFA and other industry information. Note that fees for FY19 will be published in the Federal Register 60 days before the start of the fiscal year.

Sincerely,

Elias Mallis

Director

Division of Industry and Consumer Education Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration