FDA has released the charging standards for fiscal year 2024, and the charging standards have increased again!
Release time:2023-09-07 11:38:12 The author: GRZAN source:
On July 28, 2023 local time in the United States, the FDA officially announced the fee standards for the 2024 fiscal year, and the fee implementation time is from October 1, 2023 to September 30, 2024.

On July 28, 2023 local time in the United States, the FDA officially announced the fee standards for the 2024 fiscal year, and the fee implementation time is from October 1, 2023 to September 30, 2024.

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Compared with the charges in fiscal year 2023, all charges in fiscal year 2024 will basically increase. Among them, the FDA annual fee is adjusted to $7,653, the 510K review fee is increased to $21,760, and the small and micro enterprise review fee is $5,440. In addition, De Novo requested fees of $145,068. (For specific charges, please see the picture or visit the official website for details: https://www.federalregister.gov/documents/2023/07/28/2023-15919/medical-device-user-fee-rates-for-fiscal -year-2024)