The Food & Drug Administration boosted the user fees medical device makers pay for applications for clearance or approval from the federal watchdogs.
The new fee schedule for fiscal year 2011, which goes into effect Oct. 1, institutes across-the-board hikes of 8.5 percent. Companies must pay an initial fee of $2,179 to register with the FDA.
The agency first announced its plans for the fee hike in April. Medical device companies, whose user fees have funded an increasing share of Food & Drug Administration’s device review budget, will have a chance to weigh in on how well the program is working at a Sept. 14 public workshop. The federal watchdog agency will offer its own views and solicit input from consumers, patients, healthcare professionals, scientific and academic experts at the meeting, which is scheduled a full two years ahead of the September 2012 expiration date for the current medical device user fee program.
Before FDA started collecting user fees for devices in fiscal 2003, the agency’s medical device program “suffered a long-term, significant loss of resources that undermined the program’s capacity and performance,” according to the announcement of the upcoming workshop.
The agency first won the authority to collect user fees under the 2002 Medical Device User Fee and Modernization Act. The program was reauthorized in 2007 under MDUFMA II. The user fees were supposed to make up for the FDA’s resource shortfall to help it review device applications more quickly and, ultimately, speed devices to market. In return for receiving industry funding, the FDA was tasked with meeting performance goals under MDUFMA, which set benchmarks for measuring improvements in the agency’s review times.
But the agency itself acknowledges that its record in meeting those goals has been “mixed," according to an April 20 performance report, which said it’s "unlikely" that the FDA will meet some of the goals for the PMA protocol.
Here’s how the new fees break down, comparing FY2010 rates with the upcoming fiscal year’s rates:
| 510(k) and 513(g) User Fees | |||
| Submission | 2010 Standard Fee | 2011 Standard Fee | % Increase |
|---|---|---|---|
| 510(k) | $4,007 | $4,348 | 8.5% |
| 513(g) | $2,941 | $3,191 | 8.5% |
| Small Business User Fees | |||
| Submission | 2010 Fee | 2011 Fee | % Increase |
| 510(k) | $2,004 | $2,174 | 8.5% |
| 513(g) | $1,470 | $1,595 | 8.5% |
| PMA User Fees | |||
| Submission | 2010 Standard Fee | 2011 Standard Fee | % Increase |
|---|---|---|---|
| Premarket Application | $217,787 | $236,298 | 8.5% |
| First application* | n/a | waived | |
| Panel-track Supplement | $163,340 | $177,224 | 8.5% |
| Efficacy Supplement (for BLA) | $217,787 | $236,298 | 8.5% |
| 180-day Supplement | $32,668 | $35,445 | 8.5% |
| Real-time Supplement | $15,245 | $16,541 | 8.5% |
| Annual Report | $7,623 | $8,270 | 8.5% |
| 30-day Notice | $3,485 | $3,781 | 8.5% |
| Small Business Fees | |||
| Submission | 2010 Fee | 2011 Fee | % Increase |
| Premarket Application | $54,447 | $59,075 | 8.5% |
| First application* | n/a | waived | |
| Panel-track Supplement | $40,835 | $44,306 | 8.5% |
| Efficacy Supplement (for BLA) | $54,447 | $59,075 | 8.5% |
| 180-day Supplement | $8,167 | $8,861 | 8.5% |
| Real-time Supplement | $3,811 | $4,135 | 8.5% |
| Annual Report | $1,906 | $2,068 | 8.5% |
| 30-day Notice | $1,742 | $1,890 | 8.5% |
* For firms with firms with gross receipts or sales ≤ $30 million
Leave a Reply
You must be logged in to post a comment.