mdi ConsultantsNo Surprise – Effective October 1, 2021 FDA User Fees Will Increase
These fees will be effective through September 30, 2022.
Fortunately, the increases will not be too large for FY2022.
The FDA annual registration fee for each establishment is $5,672 (in United States dollars) up from the $5546 of 2021. As previously, there are no waivers or reductions for small establishments, businesses, or groups.
The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021. If paid by October 1st it will carry through December 31, 2022.
Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. User fees are required for the following types of medical device submissions: titled 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)
- De Novo classification requests
- some PMA and PDP supplements (for example, panel-track, 180-day, real-time, 30-day notice)
- premarket reports (PMRs)
- annual fee for periodic reporting on a class III device (PMAs, PDPs, and PMRs)
- requests for device classification information (513(g)s)
- original biologics license applications (BLAs) for certain medical devices reviewed by the FDA’s Center for Biologics Evaluation and Research (CBER)
- BLA efficacy supplements
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FY2022 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Submissions To reduce the financial burden on small businesses, the Center for Devices and Radiological Health (CDRH) provides a reduced medical device user fee for some types of submissions for a certified 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. The business must apply and be certified by CDRH before they can apply the 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. For more information, please review the Medical Device User Fee Small Business Qualification and Certification Guidance. As of August 1, 2021, CDRH is accepting Small Business Determination requests for FY2022. The FY2022 Small Business status will be from time of certification through September 30, 2022. Please be aware that it can take up to 6 weeks to get the small business designation so if you want to have pay the small business fee in lieu of the regular fee you need to get the application into the FDA ASAP. FY2022 User Fees for Medical Device Submissions The following table identifies the FY2022 User Fees for Medical Device Submissions (in U.S. dollars).
† Small Business Fee: For businesses certified by CDRH as a small business. ‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. There is no user fee for a 510(k) submitted to the FDA by an FDA-accredited third-party reviewer. The FY2022 user fees apply to medical device submissions received by the FDA between October 1, 2021 and September 30, 2022. If you wish to pay the FY2022 user fee for a submission, both your submission and your user fee payment must be received by September 30, 2022. If you plan to submit a submission, the user fee payment must be received on or before the date you send the submission. The review of the submission will begin only after the FDA receives your full payment. Do not send your user fee payment to the FDA with your application. |
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Questions?
mdi will continue to monitor the FDA’s registration fee requirements as well as medical device user fees, regulatory requirements, the implementation of MDUFA IV, and other related information. You can also reach out to us for further information on products regulated by the Center for Biologics Evaluation and Research (CBER). Contact us at: [email protected] and ref: FDA User Fees FY2022.