FDA new user fees for fiscal year 2018 will leave a dent in your pockets!! “Be ready for a STICKER SHOCK”
The FDA announced the FY18 user fees in the August 28, 2017 Federal Register Notice titled Medical Device User Fee Rates for Fiscal Year 2018. The FDA notice establishes the fee rates for FY 2018 which will apply starting October 1, 2017 through September 30, 2018.
All medical device establishments are required to pay an annual establishment registration fee. For FY18, the registration fee for each establishment is $4,624 (in U.S. Dollars). As in previous years, there are no waivers or reductions for small establishments, businesses, or groups. This is a CRAZY increase of 36% over 2017 annual registration fee.
SMALL BUSINESS CAN TAKE SOME CONSOLIDATION
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.
Some HIGHLITES OF THE new fees
The 510(k) fees for Large Companies has more than doubled from $4690 up to $10,566 an increase of 125% – WOW. That will hurt. The increase for a small business company will be moderate 12%, i.e. $2642.
But companies thinking of submitting a DE NOVO application are in for a RUDE AWAKENING, especially for larger companies.
Effective FY 18, all requests for De Novo classification are subject to a user fee. Last year, De Novo had no associated user fees. For larger companies, it will now be a whopping $93,229 and for small business companies – still a hefty fee of $23,307.
The following table identifies the FY18 User Fees for Applications (in US Dollars) in comparison to the F17 User Fees:
|Application Type||Standard Fee||Small Business Fee|
|de novo classification||$93,229||$23,307|
|PMA, PDP, PMR, BLA||$234,495||$310,764||$58,624||$77,691|
|BLA efficacy supplement||$234,495||$310,764||$58,624||$77,691|
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.
Please be aware if you are looking to get the 2017 fees, you must submit those fees before the end of September and your application must be in before October 2017. Otherwise, the FDA will require you pay the difference.
REMEMBER: 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
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 email@example.com.
More information about medical device user fees and MDUFA IV may be found at the FDA MDUFA webpage? For any questions or comments or your regulatory requirement please email to firstname.lastname@example.org or use our contact form.