The Food & Drug Administration extended the comment period on its medical device user fee program until Nov. 1.
On Oct. 1, the FDA boosted the user fees medical device makers pay for applications for clearance or approval from the federal watchdogs. The new fee schedule instituted an across-the-board hike of 8.5 percent. Companies must pay an initial fee of $2,179 to register with the FDA.
The medical device industry has repeatedly expressed disapproval of the program because device clearance takes longer now than it did in 2002, when the agency instituted the user fee program. The FDA stands behind the program, which must be reauthorized before its September 2012 expiration date. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, underscored that “while user fees provide a stable source of funding, [industry money] accounts for less than 20 percent of funding for CDRH activities covered by the user fee program and only roughly 1/12 of the user fee funding provided for the agency’s human drug program.”
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The agency first announced its plans for the fee hike in April. Medical device companies, whose user fees have funded an increasing share of FDA’s device review budget, had their chance weigh in on how well the program was working at a Sept. 14 public workshop. The agency said it intends to post the transcript from the workshop on its website.
Anyone interested can submit comments electronically at Regulations.gov.
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% |
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| 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
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
