FDA has published the FY 2023 for medical device registration for FY 2023. The FDA fee for medical device registration for FY 2023 is $ 6943.

Who has to pay the medical device registration fee?

Establishments that are involved in manufacturing, processing, and packaging. labeling, relabeling, exporting, and specification development of medical devices intended for commercial distribution in the United States (U.S.), including domestic importers (including  export only), are required to register annually with the FDA

Those establishments that are required to register must also pay the medical device registration fee. There is no waiver or small business exemption for the medical device registration fee. The medical device establishments may have to pay a separate fee for 510(k), De Novo, PMA, PDP, and HDE).

Validity of the medical device registration fee.

After you pay the FY 2023 medical device registration fee and register your facility, your registration will remain valid till 31st December 2023.

Contact us if you need more information about medical device registration fee payment.