Devicemakers See Lower Fees Under MDUFA 2017
Devicemakers will pay almost $27,000 less for premarket applications for medical device user fees in fiscal year 2017.
The new fees go into effect Oct. 1 through Sept. 30, 2017. Companies will need to pay the correct fee when they submit applications or they risk having their applications rejected, the agency said in its July 28 notice. The statute authorizes the FDA to collect $140.762 million in user fees.
Similar to the fee structures announced for PDUFA, GDUFA and BsUFA, the FDA’s MDUFA fees are slightly lower across the board for FY 2017 compared to FY 2016.
For example, the standard fee for a premarket application is $234,495 for FY 2017 compared to $261,388 in FY 2016. The annual registration fee for FY 2017 is set at $3,382 compared to $3,845 in FY 2016.
There is no small business rate this year, the FDA said; however the small business rate is 25 percent of the standard full fee.
Companies wanting to qualify as a small business must have gross sales less than $100 million for the most recent tax year. Businesses with sales less than $30 million could qualify for a fee waiver for their first premarket application. Companies must include gross sales receipts for all their affiliates along with their own gross sales receipts. — Tamra Sami
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Medical Device User Fees for FY 2017 |
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Application Fee Type |
Standard Fee |
FY 2017 Standard Fee |
FY 2017 |
|
Premarket application (submitted under section 515(c)(1) of the FD&C Act, a PDP submitted under section 515(f), or a BLA) |
Base fee specified in statute at $268,443, but multiplied by 87.3538 percent |
$234,495 |
$58,624 |
|
Premarket report (submitted under section 515(c)(2) of the FD&C Act) |
100 |
$234,495 |
$58,624 |
|
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) |
100 |
$234,495 |
$58,624 |
|
Panel-track supplement |
75 |
$175,871 |
$43,968 |
|
180-day supplement |
15 |
$35,174 |
$8,794 |
|
Real-time supplement |
7 |
$16,415 |
$4,104 |
|
510(k) premarket notification submission |
2 |
$4,690 |
$2,345 |
|
30-day notice |
1.60 |
$3,752 |
$1,876 |
|
513(g) request for classification information |
1.35 |
$3,166 |
$1,583 |
|
Annual Fee Type |
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Annual fee for periodic reporting on a Class III device |
3.50 |
$8,207 |
$2,052 |
|
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(13)) |
Base fee specified in statute at $3,872, but multiplied by 87.3538 percent |
$3,382 |
$3,382 |
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Source: FDA |
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