The Medical Device User Fee Amendments (MDUFA) fees for FDAs 2023-2024 fiscal year are out now


What does this mean for you? As of October 1st, all application fees increase when submitting to the CDRH.

Are you approved for a Small Business Decision? Your current approval letter expires on September 30th and a new approval letter is required effective October 1st to stay certified by the Center for Devices and Radiological Health (CDRH) as a small business.

Establishment Registration and Listings. All establishments must pay the establishment registration fee between October 1st through the end of December. Any Registration and Listing changes cannot be completed until this annual fee is paid. If the renewal fee is not paid by end of December, your account is automatically suspended.

Let RQMIS help you with Small Business Applications for qualification approvals with the FDA and/or creating or updating your Establishment Registration and Listings.

For more information, please email or call 617-947-8459


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