Proposed US FDA Small Business User Fees for 2014 Published

The US Food and Drug Administration has proposed slight increases in user fees for medical device applications for its 2014 fiscal year.

New guidance on Medical Device User Fee Admendments (MDUFA) lays out requirements medical device companies must meet in order to qualify for reduced small business fees for FDA 510(k) reviews, premarket approvals (PMA) and other regulatory reviews.

Application Type Standard Small Business
Premarket Application $258,520 $64,630
Premarket Report $258,520 $64,630
Panel-Track PMA Supplement $193,890 $48,473
BLA Efficacy Supplement $258,520 $64,630
180-Day PMA Supplement $38,778 $9,695
Real-Time PMA Supplement $18,096 $4,524
Premarket Notification (510(k)) $5,170 $2,585
30-Day Notice $4,136 $2,068
513(g) Request $3,490 $1,745
Annual Fee for Class III device reporting $9,048 $2,262

Medical device establishment registration fees will also increase to $3,313 at the start of the FDA's 2014 fiscal year. No small business reductions are available for this particular fee.

Currently, the FDA charges $4,960 for a 510(k) device review ($2,480 for small business applicants), $248,000 for PMA reviews ($62,000 for small businesses) and $2,575 for establishment registration. 

As in previous years, US companies eligible for reduced fees must qualify as "small businesses"--gross sales of $100 million or less for the most recent tax year. Foreign companies may also qualify for reduced application fees following FDA review of their National Taxing Authority Certification.

The new fee schedule goes into effect September 30, 2013.

Stewart Eisenhart

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