Health Reform WK-EDGE FDA sets user fees for medical devices, generic drugs, and third-party certification
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Friday, September 1, 2017

FDA sets user fees for medical devices, generic drugs, and third-party certification

By Bryant Storm, J.D.

The FDA published notices announcing the annual fee rate and payment procedures for the 2018 medical device and generic drug user fees and the annual fee rate for Food Safety Modernization Act (FSMA) third-party certification program accreditation bodies. The notices provide information on how the FY 2018 fees were determined and describes the payment procedures sponsors and establishments should follow to comply with these user fees. The fee rates will remain effective from October 1, 2017 through September 30, 2018 (Notice, 82 FR 41026, August 29, 2017; Notice, 82 FR 41029, August 29, 2017; Notice, 82 FR 41035, August 29, 2017).

Generic drug. The generic drug user fee authorizes the FDA to collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. The FDA calculated the ANDA fee by dividing the number of full application equivalents (FAEs) that will pay the fee in FY 2018 (948) into the fee revenue amount to be derived from ANDA application fees in FY 2018 ($162,888,000). The ANDA fee for 2018 will be $171,823 per ANDA. The agency calculated a DMF fee of $47,829 for FY 2018. The domestic FDF facility fee is $211,087 and the foreign FDF facility fee is $15,000 more, or $226,087. The domestic CMO facility fee is $70,362 and the foreign CMO facility fee is $15,000 more, or s $85,362. The large size operation generic drug applicant fee is $1,590,792, whereas the medium and small size generic drug applicant fees are $636,317 and $159,079, respectively.

Device. Medical device user fee rates are calculated from a statutorily established base rate and adjusted for inflation and to achieve specified revenue amounts. The 2018 standard premarket application (PMA) fee is $310,764 and the 2018 small business PMA fee is $77,691. The standard 510(k) premarket notification submission fee is $10,566, whereas the small business version of that fee is $2,642. The annual establishment registration fee, which must be paid by any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, is $4,624, regardless of business size.

Third-party certification program. Under 21 U.S.C. § 384d, the FDA established a program for accreditation of third-party certification bodies tasked with conducting food safety audits and issuing food and facility certifications to eligible foreign entities. The statute established a user fee program to fund the accreditation process. The FDA estimated the hourly rate for supporting direct FDA work at $231 per hour, increasing that figure to $285 per hour, if travel is required. The FDA set the initial application fee for an accreditation body seeking recognition at $37,935. The 2018 annual fee for a recognized accreditation body is $1,752 and the annual Fee for an accredited certification body is $2,190.

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