mdi ConsultantsYes, the FDA has come out with the new FDA user fees for 2024. And as you can imagine the FDA is raising all fees from the annual registration to the 510(k)s.
Annual Establishment Registration Fee for the coming year will be: $7,653 (talk about inflation – that is a 17% increase in the annual fee).
The new 510(k) for small business is being increased around 10% to $5440.
DeNovo fees also will increase about 10% to $36,267.
Below is the schedule for the 2024 FDA fees for medical device company and submissions.
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2024.
Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
|
Application Type |
Standard Fee |
Small Business Fee† |
|
510(k)‡ |
$21,760 |
$5,440 |
|
513(g) |
$6,528 |
$3,264 |
|
PMA, PDP, PMR, BLA |
$483,560 |
$120,890 |
|
De Novo Classification Request |
$145,068 |
$36,267 |
|
Panel-track Supplement |
$386,848 |
$96,712 |
|
180-Day Supplement |
$72,534 |
$18,134 |
|
Real-Time Supplement |
$33,849 |
$8,462 |
|
BLA Efficacy Supplement |
$483,560 |
$120,890 |
|
30-Day Notice |
$7,737 |
$3,869 |
|
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) |
$16,925 |
$4,231 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
‡ 510(k) Fees: 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. (though you will be paying an much higher fee for their review so you are not getting any break).
More Inforamtion
If you have any questions on the FDA user fees for 2024 please contact mdi at: [email protected] and RE: FDA user fees 2024
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