| | FY21 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device SubmissionsTo reduce the financial burden on small businesses, the FDA reduces the medical device 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.
Any business, regardless of location, may apply to be certified as a small business. We will begin accepting Small Business Requests for FY2021, starting on August 1, 2020. FY 2021 Small Business status will be from time of approval through September 30, 2021. | FY2021 User Fees for Medical Device SubmissionsThe following table identifies the FY21 User Fees for Medical Device Submissions (in U.S. dollars). - 510(k)‡ - Standard Fee $12,432. Small Business Fee $3,108.
- 513(g) - Standard Fee $4,936. Small Business Fee $2,468.
- PMA, PDP, PMR, BLA - Standard Fee $365,657. Small Business Fee $91,414.
- De Novo Classification Request - Standard Fee $109,697. Small Business Fee $27,424
- Panel-track Supplement - Standard Fee $274,243. Small Business Fee $68,561.
- 180-Day Supplement - Standard Fee $54,849. Small Business Fee $13,712.
- Real-Time Supplement - Standard Fee $25,596. Small Business Fee $6,399.
- BLA Efficacy Supplement - Standard Fee $365,657. Small Business Fee $91,414.
- 30-Day Notice - Standard Fee $5,851. Small Business Fee $2,926.
- Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) - Standard Fee $12,798. Small Business Fee $3,200.
† For small businesses with an approved small business determination.
‡ 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 FY2021 user fees apply to medical device submissions received by the FDA on or after October 1, 2020. If you wish to pay the FY2021 user fee for a submission, both your submission and your user fee payment must be received prior to October 1, 2021.
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. For additional information or instructions regarding how to submit the fee, please visit the | For More InformationIf 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 Medical Device User Fee Amendments (MDUFA) website. On this site, you may also sign up to receive updates each time FDA updates information about MDUFA and other information relevant to the device industry. Fees for FY2022 will be published in the Federal Register 60 days before the start of that fiscal year.
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