September 15, 2019

September 13, 2019

Subscribe to Latest Legal News and Analysis

September 12, 2019

Subscribe to Latest Legal News and Analysis

FDA FY 2017 Medical Device User Fees Announced

On July 29, 2016, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2017, which applies from October 1, 2016 through September 30, 2017. The FY 2017 user fees declined from the previous year’s rates.

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended by the Medical Device User Fee Amendments of 2012 (“MDUFA III”), FDA is authorized to collect user fees for certain medical device submissions as well as annual fees for periodic reports of class III devices and registration for certain establishments.

FDA’s announcement describes the procedures to qualify as a small business. If a business has gross receipts or sales of no more than $100 million for the most recent tax year, the business may qualify for reduced “small business” fees.  However, there is no “small business” reduction in the establishment registration fee.  FDA’s announcement also includes information concerning the procedures for paying fees.

The fee rate for each submission type and for periodic reporting is based upon a specified percentage of the standard fee for a premarket application (“PMA”). The following are the FY 2017 standard user fees:

  • PMA: $234,495

  • Panel-track supplement: $175,871

  • 180-day supplement: $35,174

  • Real-time supplement: $16,415

  • 510(k) premarket notification submission: $4,690

  • 30-day notice: $3,752

  • 513(g) request for classification information: $3,166

  • Annual fee for periodic reporting on a class III device: $8,207

  • Annual establishment registration fee: $3,382

According to the Agency’s announcement, the fee you must pay is the fee that is in effect on the later of the date that your application is received by the Agency or the date your fee payment is recognized by the U.S. Treasury.

© 2019 Covington & Burling LLP

TRENDING LEGAL ANALYSIS


About this Author

Chris Hanson, Food and Drug Attorney, Covington Law Firm
Associate

Christopher Hanson advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, cosmetics, animal products, and radiation-emitting electronic products. His broad range of clients include large multinational companies, venture capital firms, industry associations, clinical laboratories, and development-stage companies.

Mr. Hanson has extensive experience counseling clients on interactions with state, federal, and foreign regulatory agencies, including the Food and Drug Administration (...

202-662-5977