US FDA reduces medical device 510(k) registration fees 10% for 2017

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration’s medical device registration user fees for the agency’s 2017 fiscal year have decreased nearly across the board, including 10% reductions for 510(k) premarket notifications.

The 2017 user fee reductions stem from offset provisions of the Federal Food, Drug & Cosmetic Act, which came into effect after the FDA reported fee collections that exceeded appropriated cumulative amounts between the regulator’s 2013 and 2016 fiscal years.

As a result, “the excess shall be credited to the appropriation account of the Food and Drug Administration and shall be subtracted from the amount of fees that would otherwise be authorized to be collected for FY 2017,” states the FDA’s notice on its 2017 user fees.

Standard user fees for the 2017 fiscal year decreased for all categories except for those pertaining to Premarket Authorizations (PMA):

Application Type	Standard Fee 2017	Standard Fee 2016	Increase (Decrease)
510(k)	$4,690	$5,228	($538)
513(g)	$3,166	$3,529	($363)
PMA, PDP, PMR, BLA	$234,495	$216,388	$18,107
Panel-track Supplement	$175,871	$191,041	($15,170)
180-day Supplement	$35,174	$39,208	($4,034)
Real-time Supplement	$16,415	$18,297	($1,882)
BLA Efficacy Supplement	$234,495	$216,388	$18,107
PMA Annual Report	$8,207	$9,149	($942)
30-day Notice	$3,752	$4,182	($430)

User fees for small businesses will decrease across all categories, including for PMAs:

Application Type	Small Business Fee 2017	Small Business Fee 2016	Increase (Decrease)
510(k)	$2,345	$2,614	($269)
513(g)	$1,583	$1,765	($182)
PMA, PDP, PMR, BLA	$58,624	$65,347	($6,723)
Panel-track Supplement	$43,968	$49,010	($5,042)
180-day Supplement	$8,794	$9,802	($1,008)
Real-time Supplement	$4,104	$4,574	($470)
BLA Efficacy Supplement	$58,624	$65,347	($6,723)
PMA Annual Report	$2,052	$2,287	($235)
30-day Notice	$1,876	$2,091	($215)

 

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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