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.
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