Food & Drug Administration drops user fees for medical device companies
WELL, FINALLY SOME GOOD NEWS FOR THE MEDICAL DEVICE INDUSTRY
The Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year 2012.
The U.S. Food & Drug Administration will drop user fees for medical device companies by about 7 percent across the board in 2012. FDA said “Because of the requirement to give back to industry any funds received in excess of the total fee amount enacted by Congress for the first four years of the MDUFA II, we are lowering user fees in FY 2012 in order to give back to industry about $9.5 million rather than spend those funds to improve our premarket review programs.”
Here is the update fee structure:
FY 2012 Fees for Review of Premarket Notification Submissions [510(k)s] and Requests for Information Regarding Classification [513(g)s]
|
FY 2012 Device Review User Fees (U.S. Dollars)
|
|
Submission
|
Standard Fee
|
Small Business (≤$100 million in gross receipts or sales) Fee
|
|
510(k)
|
$4,049
|
$2,024
|
|
513(g)
|
$2,971
|
$1,485
|
FY 2012 Fees for Review of Premarket Applications
|
FY 2012 Device Review User Fees (U.S. Dollars)
|
|
Submission
|
Standard
Fee
|
Small Business Fee
|
|
Premarket Application (PMA, PDP, BLA, PMR)
|
$220,050
|
$55,013
|
|
First premarket application from firms with gross receipts
or sales ≤ $30 million
|
Not Applicable
|
Fee is Waived
|
|
Panel-track Supplement
|
$165,038
|
$41,259
|
|
Efficacy Supplement (for BLA)
|
$220,050
|
$55,013
|
|
180-day Supplement
|
$33,008
|
$8,252
|
|
Real-time Supplement
|
$15,404
|
$3,851
|
|
Annual Report
|
$7,702
|
$1,925
|
|
30-day Notice
|
$3,521
|
$1,760
|
Now, if the FDA can increase their responsiveness and ODE time frames maybe this would be a real good for the industry.
Fees for FY 2013 will be published in the Federal Register 60 days before the start of the fiscal year.
For more information on the fees please email us at info@mdiconsultants.com and Ref: Fees for 2012.