EMERGO SUMMARY OF KEY POINTS:
- US FDA medical device user fees will increase by about four percent for the agency’s 2019 fiscal year.
- Revised user fees take effect starting October 1, 2018.
- The latest FDA user fee increases are much less substantial than those put in place last year.
US Food and Drug Administration user fees for medical device registrations including 510(k) and Premarket Approval (PMA) applications will increase for the agency’s 2019 fiscal year at a much slighter rate than for 2018.
The latest FDA user fee schedule will increase fees based on total revenue inflation adjustment by about four percent for both standard and small-business applications and related regulatory submissions. The new fees will apply starting October 1, 2018 until September 30, 2019. (Companies hoping to avoid the four-percent fee increase should submit their US market applications by September 30, 2018 to qualify for 2018 fee rates.)
Less dramatic fee hikes for US market registrants
Under the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA raised many user fees by 33% or more, and more than doubled the standard fee for 510(k) premarket notification submissions. In addition, FDA began assessing substantial fees for De Novo device applications for the first time last year.
Standard registration fees for FDA’s 2019 fiscal year are shown below:
|
Application Type |
Standard Fee 2019 (USD) |
Standard Fee 2018 (USD) |
|
510(k) |
10,953 |
10,566 |
|
513(g) |
4,349 |
4,195 |
|
PMA/PDP/PMR/BLA |
322,147 |
310,764 |
|
Panel-track Supplement |
241,610 |
233,073 |
|
180-day Supplement |
48,322 |
46,615 |
|
Real-time Supplement |
22,550 |
21,753 |
|
BLA Efficacy Supplement |
322,147 |
310,764 |
|
PMA Annual Report |
11,275 |
10,877 |
|
30-day Notice |
5,154 |
4,972 |
|
De Novo |
96,644 |
93,229 |
Device manufacturers with sales of $100 million or less for the most recent tax year may qualify for discounted small-business user fees under the FDA Center for Devices and Radiological Health (CDRH) Small Business Program. These fees also saw roughly four-percent increases for 2019:
|
Application Type |
Small Business Fee 2019 (USD) |
Small Business Fee 2018 (USD) |
|
510(k) |
2,738 |
2,642 |
|
513(g) |
2,175 |
2,098 |
|
PMA/PDP/PMR/BLA |
80,537 |
77,691 |
|
Panel-track Supplement |
60,403 |
58,268 |
|
180-day Supplement |
12,081 |
11,654 |
|
Real-time Supplement |
5,638 |
5,438 |
|
BLA Efficacy Supplement |
80,537 |
77,691 |
|
PMA Annual Report |
2,819 |
2,719 |
|
30-Day Notice |
2,577 |
2,486 |
|
De Novo |
24,161 |
23,367 |
Minor FDA Establishment Registration fee increases
FDA Establishment Registration fees are also slated for a five-percent increase in 2019, to $4,884 from $4,642 in 2018. FDA typically requires companies that manufacture all or part of their devices within the US or perform processing such as sterilization to obtain Establishment Registrations on an annual basis in addition to their US market registrations. (FDA does not offer small-business discounts for Establishment Registration fees.)
Additional US medical device regulatory resources from Emergo:
- US FDA medical device Establishment Registration consulting
- FDA 510(k) consulting for medical device and IVD companies
- FDA medical device classification consulting
Author
- Stewart Eisenhart