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NEW FDA APPLICATION FEE FOR MEDIC


Medical device user fee for fiscal year (FY) 2018 had been increased, which apply from October 1, 2017, through September 30, 2018.

Before submitting your application to the FDA, you should pay the fee to avoid delay in the revision of your application. The fee has been updated, you must pay the fee in effect on the day your application is received by the FDA or the day your payment is recognized by the US Treasury.

Please note that to pay a reduced small business fee, you must be qualified as a small business, otherwise you will have to pay the higher standard fee.

The following table shows fees for medical devices according to the agency Food and Drug Administration:

 

Application fee type

Standard fee (as a percent of the standard fee for a premarket application)

FY 2018 standard fee

FY 2018 small business fee

Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))

 

Base fee specified in statute

$310,764

$77,691

Premarket report (submitted under section 515(c)(2) of the FD&C Act)

 

100

310,764

77,691

Efficacy supplement (to an approved BLA under section 351 of the PHS Act)

 

100

310,764

77,691

Panel-track supplement

 

75

233,073

58,268

De novo classification request

 

30

93,229

23,307

180-day supplement

 

15

46,615

11,654

Real-time supplement

 

7

21,753

5,438

510(k) premarket notification submission

 

3.40

10,566

2,642

30-day notice

 

1.60

4,972

2,486

513(g) request for classification information

1.35

4,195

2,098

Annual fee for periodic reporting on a class III device

3.50

10,877

2,719

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

4,624

4,624