DEVICE USER FEES OF $105,000 FOR PMAs AND PLAs, $5,900 FOR 510(K)s PROPOSED IN DRAFT BILL; SPONSORS OF PENDING APPLICATIONS WOULD BE ASSESSED HALF PRICE
This article was originally published in The Gray Sheet
Executive Summary
Device submission user fees would be set at $105,000 for premarket approval and product license applications and $5,900 for 510(k)s under an April 12 discussion draft of user fee legislation formulated by the majority staff of the House Energy and Commerce Committee. The draft would set fees of $55,000 for premarket approval supplements that include required clinical data and $5,900 for PMA supplements without clinical data.