viernes, 29 de septiembre de 2017

FY18 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Applications

Today, the FDA’s Center for Devices and Radiological Health (CDRH) is pleased to announce a new web page on Device Advice that summarizes CDRH’s Small Business Program.

The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of these user fees. Application types eligible for reduced small business fee are: Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application [PMA], Biologics License Application [BLA], Product Development Protocol [PDP]), Premarket Report (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information. See the full list of eligible application types at the MDUFA User Fees website.

To be eligible for a reduced small business fee, you must qualify as a “small business.” This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year. If you have any affiliates, you must add their gross receipts or sales to yours, and the total must be no more than $100 million. In addition, small businesses with gross receipts or sales of $30 million or less are eligible to have the fee waived for their first PMA, PDP, PMR or BLA.

In order to receive a small business fee waiver or reduction, the FDA must approve your application for a Small Business Determination (SBD).  On this Device Advice webpage, the following information is provided:
  • how to submit an application,
  • frequently asked questions, and
  • additional SBD Program resources.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or at

Food and Drug Administration
Center for Devices and Radiological Health 

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