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FY 2020 MDUFA User Fees(2020财年FDA医疗器械企业年费USD5236

FY 2020 MDUFA User Fees

The Fees for Fiscal Year 2020 (October 1, 2019 through September 30, 2020) are as follows:

Application TypeStandard FeeSmall Business Fee†
510(k)‡$11,594$2,899
513(g)$4,603$2,302
PMA, PDP, PMR, BLA$340,995$85,249
De Novo Classification Request$102,299$25,575
Panel-track Supplement$255,747$63,937
180-Day Supplement$51,149$12,787
Real-Time Supplement$23,870$5,968
BLA Efficacy Supplement$340,995$85,249
30-Day Notice$5,456$2,728
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$11,935$2,984

For small businesses with an approved SBD

Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived

on their first PMA, PDP, PMR, or BLA.


Annual Establishment Registration Fee: $5,236.

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There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.


https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa


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