US FDA Reduces Medical Device 510(k) Registration Fees 10% for 2017

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.

US FDA medical device user fees for 2017The 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)

Sources: FDA, Emergo

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)

Sources: FDA, Emergo

Reduced establishment registration fees, too

The FDA has also reduced its annual establishment registration fees by 12%, from $3,845 in 2016 to $3,382 for 2017. Any company involved in medical device or IVD production, importation or distribution in the US must maintain establishment registration on a yearly basis and pay the associated fee.

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