BUSINESS NEWS
In August, FDA published its user fee rates for 2007. The fees were introduced four years ago as a provision of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The legislation was intended to provide resources to facilitate the FDA review process required before devices are approved and marketed.
The law was amended last August by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA) to ensure continuation of the program, which was threatened by shortfalls in congressional funding and less-than-anticipated industry fees. MDUFSA ensured full government support and set maximum fee increases for both fiscal year 2006 and fiscal year 2007.
The 2007 user fee rates for both premarket approval (PMA) applications and 510(k) applications represent an increase of 8.5%—the maximum allowable under the MDUFSA guidelines. The PMA fee will increase to $281,600 while the 510(k) fee rises to $4158. For small medtech firms—those with less than $100 million in revenue—the PMA fee is $107,008 and the 510(k) fee is $3326. Companies with annual revenues of less than $30 million remain eligible for a waiver on their first PMA. The new fees go into effect October 1 of this year. Industry reaction to the 2007 user fee rates was largely muted since the increases were generally expected in light of the MDUFSA guidelines. The user fee program will sunset on September 30, 2007, unless it is reauthorized by Congress. FDA and various industry stakeholders have been working on the continuation of the program—known as MDUFMA II—since last year.
|
Application
Fee Type
|
Cost
in Relation to
Premarket Approval Application Feel (%) |
FY07
Full Fee ($) |
FY07
Small Business ($) |
| Premarket
approval (PMA) application |
—
|
281,600
|
107,008
|
| Premarket report |
100
|
281,600
|
107,008
|
| Panel-track supplement |
100
|
281,600
|
107,008
|
| Efficacy supplement |
100
|
281,600
|
107,008
|
| 180-day supplement |
21.5
|
60,544
|
23,007
|
| Real-time supplement |
7.2
|
20,275
|
7,705
|
| Premarket notification (510(k)) |
1.42
in aggregate
|
4,158
|
3,326
|
| FDA table of medical device user fees for fiscal 2007, showing application types, the coste of each application as a percentage of the full premarket approval (PMA) application fee, and the full and small-business fee rates. Fees are effective for all of the listed application types submitted to FDA from October 1, 2006, through September 30, 2007. Source: "Medical Device User Fee Rates for Fiscal Year 2007," Federal Register 71, no. 148 (August 2, 2006): 43784–43786. | |||
Full details about FDA's 2007 user fee rates as published in the Federal Register are available at www.fda.gov/OHRMS/DOCKETS/98fr/E6-12394.pdf.
