Walter Eisner • Thu, August 7th, 2014
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.