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

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

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). Application Type Standard Fee Small Business Fee† 510(k)‡ 10,953 2,738 513(g) 4,349 2,175 PMA, PDP, PMR, BLA 322,147 80,537 De Novo classification request 96,644 24,161 panel-track supplement 241,610 60,403 180-day supplement 48,322 12,081 real-time supplement 22,550 5,638 BLA efficacy supplement 322,147 80,537 annual report 11,275 2,819 30-day notice 5,154 2,577 †  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 beforethe 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. For More Information If you have questions regarding medical device user fees, regulatory requirements, or other related information, please contact the 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. Questions regarding products regulated by the Center for Biologics Evaluation and Research (CBER) should be directed to the 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. Further information regarding medical device user fees and the implementation of MDUFA IV is available on the FDA’s Medical Device User Fee Amendments (MDUFA) website. On this site, you can also sign up to receive updates each time FDA updates information about MDUFA and other information relevant to the device industry. Fees for FY20 will be published in the Federal Register 60 days before the start of that 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