New U.S. FDA Medical Device User Fees for FY 2015

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The U.S. FDA released medical device user fee rates and payment procedures for FY 2015. Registrar Corp explains the fees and payment process to the industry.

Registrar Corp Assists Companies with U.S. FDA Regulations
Procedures for paying FDA medical device application and annual establishment fees are very specific and should be carefully followed.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device applications, for annual fees for certain periodic reports, and for establishments subject to registration. On July 31, 2014, FDA announced the medical device user fee rates and payment procedures for fiscal year (FY) 2015, effective October 1, 2014 through September 30, 2015.

These fees include:

  • Premarket application standard fee: $250,895
  • Premarket application small business fee: $62,724
  • Annual periodic reporting standard fee for class III device: $8,781
  • Annual periodic reporting small business fee for class III device: $2,195
  • Annual establishment registration standard fee and small business fee: $3,646
  • 510(k) premarket notification submission standard fee: $5,018
  • 510(k) premarket notification submission small business fee: $2,509
  • 513(g) (21 U.S.C. 360c(g) request for classification information standard fee: $3,387
  • 513(g) (21 U.S.C. 360c(g)request for classification information small business fee: $1,694

There were 24,462 establishments that paid annual registration fees in 2013. Annual establishment registration fees must be paid by all domestic and foreign establishments that manufacture, prepare, propagate, compound, assemble, or process medical devices, and there is no reduction in price for small businesses. Most establishments are also required to list the devices at the establishment and the activities performed on those devices. Procedures for paying application and establishment fees are very specific and should be carefully followed.

Registrar Corp’s Regulatory Specialists can assist with payment procedures and ensure your medical device establishment is properly registered and your devices properly listed. For more information on medical device fees and application processes or any other FDA regulations contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists:

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations

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David Lennarz

Liviana Callahan
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