2023 미국 FDA 등록비용 FY 2023 - FDA Medical Device Registration Fees

User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are: Application Type Standard Fee Small Business Fee† 510(k) $19,870 $4,967 513(g) $5,961 $2,980 PMA, PDP, PMR, BLA $441,547 $110,387 De Novo Classification Request $132,464 $33,116 Panel-track Supplement $3...