CDRH Letter Outlines New User Fee Amounts
CDRH has sent out a letter to medical device establishments to provide information about device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which begins 10/1.The letter notes that the annual establishment registration fee must be paid between 10/1 and 12/31. For FY18, the registration fee for each establishment is $4,63). All establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to pay this fee.
The following table identifies the FY18 user fees for applications:
|
Application type |
Standard fee |
Small business fee† |
|
510(k) |
10,542 |
2,636 |
|
513(g) |
4,186 |
2,093 |
|
De Novo classification |
93,017 |
23,254 |
|
PMA, PDP, PMR, BLA |
310,058 |
77,515 |
|
panel-track supplement |
232,544 |
58,156 |
|
180-day supplement |
46,509 |
11,627 |
|
real-time supplement |
21,704 |
5,426 |
|
BLA efficacy supplement |
310,058 |
77,515 |
|
annual report |
10,852 |
2,713 |
|
30-day notice |
4,961 |
2,481 |