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US FDA Sets Some Steep Increases for 2023 Medical Device User Fees

The FDA released its 2023 medical device user fees and some have increased sharply since last year.

US FDA formally proposes aligning Quality System Regulations with ISO 13485

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.