Medical Device Fees for FY 2013
Fees Relating to Medical Device Applications
Application Type
Standard Fee
Small Business
Premarket Application (PMA, BLA, PDP)
$248,000
$62,000
Premarket report (for a reprocessed single-use device)
$248,000
$62,000
Panel-track PMA supplement
$186,000
$46,500
BLA efficacy supplement
$248,000
$62,000
180-day PMA supplement
$37,200
$9,300
Real-time PMA supplement
$17,360
$4,340
510(k) premarket notification
$4,960
$2,480
30-day notice
$3,968
$1,984
513(g) request for classification information
$3,348
$1,674
Annual fee for periodic reporting on a class III device
$8,680
$2,170
Establishment Registration Fee — There is no reduced fee for a small business. If this is the only fee you expect to pay during FY 2013, you should not submit an FY 2013 Certification.
Type of Fee
Annual Fee
Establishment registration fee
$2,575
