December 5, 2022
The US Food and Drug Administration announced that it has set medical device user fees for fiscal year 2023. Medical device manufacturers and importers seeking to sell their products in the US market can expect substantial increases in some fees compared with those for 2022. The fee increases take effect at the beginning of FDA’s 2023 fiscal year, which began October 1, 2022. Notably, FDA is switching to a five-year user fee program, meaning these fees run through September 20, 2027.
Remarkably, the 510(k) premarket notification fee saw an increase of 56%, while the increases for De Novo Classification and Premarket Approval (PMA) both came in at 18%.
Standard FDA medical device user fees for 2023
|
Application Type |
FYE 2023 (USD) |
FYE 2022 (USD) |
|
510(k) |
19,870 |
12,745 |
|
513(g) |
5,961 |
5,061 |
|
PMA |
441,547 |
374,858 |
|
De Novo |
132,464 |
112,457 |
|
Panel-track Supplement |
353,238 |
281,143 |
|
180-day Supplement |
66,232 |
56,229 |
|
Real-time Supplement |
30,908 |
26,240 |
|
PMA Annual Report |
15,454 |
13,120 |
|
30-day notice |
7,065 |
5,998 |
Medical device registrants that qualify as small businesses will continue to qualify for discounted user fee rates. Businesses with $100 million or less in sales for their most recent tax year qualify for the small business discounted fees.
Small business user fees for 2023
|
Application Type |
FYE 2023 (USD) |
FYE 2022 (USD) |
|
510(k) |
4,967 |
3,186 |
|
513(g) |
2,980 |
2,530 |
|
PMA |
110,387 |
93,714 |
|
De Novo |
33,116 |
28,114 |
|
Panel-track Supplement |
88,309 |
70,286 |
|
180-day Supplement |
16,558 |
14,057 |
|
Real-time Supplement |
7,727 |
6,560 |
|
PMA Annual Report |
3,864 |
3,280 |
|
30-day notice |
3,532 |
2,999 |
Emergo by UL will continue to post updates to FDA guidance as they become available.
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