FDA update 9th August 2011

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.