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The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).

Medical Device User Fees for FY 2017

  • Establishment Registration Fee: $3,382 (No Reduction for Small Businesses)
  • Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small Businesses
  • Premarket Notification (510(k)): $4,690 / $ 2,345 for Small Businesses
  • 513(g) request for classification information: $3,166 / $1,583 for Small Businesses
  • PMA Annual Report: $8,207 / $2,052 for Small Businesses

FDA’s FY 2017 medical device user fees show a decrease from FY 2016.

Registrar Corp can register medical device establishments with U.S. FDA as well as review a 510(k) for compliance with submission requirements.

Generic Drug User Fees for FY 2017

Application Fees:

  • Abbreviated New Drug Application (ANDA): $70,480
  • Prior Approval Supplement (PAS) to an ANDA: $35,240
  • Drug Master File (DMF): $51,140

Facility Fees:

  • Active Pharmaceutical Ingredient (API)—Domestic: $44,234
  • API—Foreign: $59,234
  • Finished Dosage Form (FDF)—Domestic: $258,646
  • FDF—Foreign: $273,646

FDA’s FY 2017 ANDA and PAS application fees show a decrease from FY 2016.   The FY 2017 DMF application fee as well as the API and FDF facility fees show an increase from FY 2016.

Registrar Corp can register a drug establishment and file DMFs with U.S. FDA.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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