FDA medical device user fees are going down by 3%.
Medical device companies pay the fee to have their products reviewed by the agency. The cuts are for the government’s 2015 fiscal year.
The CDRH (Center for Devices & Radiological Health) division of the agency said on July 30, 2014, it proposes to cut the fees 3% for both large and small businesses regardless of the company’s annual revenue.
According to the Federal Register, the fiscal 2015 rates would see PMA (premarket approval) applications cost $250, 895 for large companies (down from $258, 520), with small-business PMAs running $62, 724 (down from $64, 630). Applications for 510(k) clearances would cost $5, 018 (down from $5, 170) for large firms and $2, 509 (down from $2, 585) for small businesses. Set to go into effect October 1, 2014 the new fees would generate an estimated $131.2 million for the FDA.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees.
Savings Start October 1
But don’t count your savings just yet. You still have to pay the old amount until October 1.
To avoid delay in the review of your application, the agency says you should pay the standard fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA.
To read the details of the new fee schedule visit http://www.gpo.gov/fdsys/pkg/FR-2014-07-30/html/2014-17902.htm.
