User Fees Set for FY2013: Schedule Matches MDUFA

The fiscal 2013 medical device user fee rates laid out in a Federal Register notice match amounts set during MDUFA negotiations between the agency and industry representatives.
Fee amounts are as follows:

• Base fee for PMA — $248,000; $62,000 for small businesses.
• 515(c)2 premarket report — $248,000; $62,000 for small businesses.
• Efficacy supplement to an approved BLA — $248,000; $62,000 for small businesses.
• Panel-Track supplement — $186,000; $46,500 for small businesses.
• 180-day supplement — $37,200; $9,300 for small businesses.
• Real-time supplement — $17,360; $4,340 for small businesses.
• 510(k) submission — $4,960; $2,480 for small businesses.
• 30-day notice — $3,968; $1,984 for small businesses.
• 513(g) request for classification information — $3,348; $1,674 for small businesses.
• Annual establishment registration fee — $2,575; no small business deduction.
• Annual fee for periodic reporting on a Class III device — $8,680; $2,170 for small businesses.

Devices & Diagnostics Letter