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. This guidance describes the process for how a business may request qualification and certification as a small business.

For purposes of this guidance, note, there should be a National Taxing Authority within the Foreign Government who will be responsible for completion of the appropriate sections of the Form FDA 3602A. In this guidance, we will refer to “Foreign Government” and “National Taxing Authority” interchangeably.

Posted on the FDA website on 29 August 2017