FDA update 9thAugust 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 Fees for Review of Premarket Applications

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.