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Possibility of reducing FDA registration fees for medical devices

Like ANVISA, FDA allows different medical device registration fee values to be applied according to the company’s annual revenue. This benefit is granted to both American and foreign companies.

Medical device manufacturers whose annual billing is less than $ 100 million are likely to declare themselves a “Small Business” and can benefit from a substantial discount. To apply for it, it is necessary to send a formal request to FDA. Passarini Regulatory Affairs can help you, contact us.

For a 510 (k) process, the fee reduction obtained reaches almost 76% of the standard value as can be seen in the comparative table below, which shows the standard fee and reduced fee values by submission type.

Submission type Fee FY 2019 ($)
Standard Small Business
510(k) 10,953 2,642
513(g) 4,349 2,098
PMA/PDP/PMR/BLA 322,147 77,691
De Novo 96,644 23,367
PMA Annual Report 11,275 2,719

This fee reduction is valid for the current fiscal year, which began on October 1 2018 and will run through September 30 2019.

For registration processes to be submitted after September 30, a new Small Business request must be made.

Note that the benefit of fee reduction for businesses qualified as Small Business is not applicable to the Establishment annual fee, which for fiscal year 2019 is of $ 4,884.

The FDA guidance on this topic is available at the link below:

Click here

For more information and explanations about it, send us an e-mail: [email protected]

Passarini Regulatory Affairs

Published: 03/26/2019

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