The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over.
The watchdog agency announced new rates for the fees in August, but couldn’t begin collecting them when the fiscal year began Oct. 1 because of the shutdown that began that day.
The new fee rates show a 4.2% across-the-board increase from fiscal 2013 for both small businesses making less than $100 million and their larger counterparts.
The fiscal 2014 rates will see pre-market approval applications cost $258,520 for large companies, with small-business PMAs paying $64,630. Applications for 510(k) clearances would cost large corporations $5,170 and small businesses $2,585.
Here’s a comparison of the new user fee schedule for fiscal 2014 with the user fee rates for this fiscal year:
| Application type | Fee for FY2013 | Fee for FY2014 (proposed) | Percentage increase | Small business fee FY2013 | Small business fee FY2014 | Percentage increase |
| 510(k) | $4,960 | $5,170 | 4.2% | $2,480 | $2,585 | 4.2% |
| 513(g) | $3,348 | $3,490 | 4.2% | $1,674 | $1,745 | 4.2% |
| PMA, PDP, PMR, BLA | $248,000 | $258,520 | 4.2% | $62,000 | $64,630 | 4.2% |
| panel-track supplement | $186,000 | $193,890 | 4.2% | $46,500 | $48,473 | 4.2% |
| 180-day supplement | $37,200 | $38,778 | 4.2% | $9,300 | $9,695 | 4.2% |
| Real-time supplement | $17,360 | $18,096 | 4.2% | $4,340 | $4,524 | 4.2% |
| BLA efficacy supplement | $248,000 | $258,520 | 4.2% | $62,000 | $64,630 | 4.2% |
| Annual report | $8,680 | $9,048 | 4.2% | $2,170 | $2,262 | 4.2% |
| 30-day notice | $3,968 | $4,136 | 4.2% | $1,984 | $2,068 | 4.2% |
