Regulatory Focus™ > News Articles > FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

Posted 31 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released new guidance on how small medical device companies can qualify as an FDA-approved small business and be eligible to pay reduced fees under the Medical Device User Fee Act (MDUFA).

FDA's Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification notes small businesses are authorized to pay "substantially reduced" fees under the terms of MDUFA, and are even eligible to receive a one-time waiver of fees for their first-ever premarket application (PMA), biologics license application (BLA), product development protocol (PDP) or premarket report.

Small businesses are not eligible for reduced facility registration fees, which are the same for all applicants. All other application fees are reduced, with some offering small businesses significant savings. A small business submitting a PMA or BLA, for example, would pay approximately $55,000 to FDA in fees. A normal-sized or large business would pay more than $220,000 for submitting the same PMA or BLA.

To qualify, businesses must have gross receipts or sales of less than $100 million-in combination with any corporate affiliates and subsidiaries-during the most recent fiscal tax year. US-based firms meeting this criterium are encouraged to fill out Form FDA 3602, while foreign-based firms are encouraged to fill out Form FDA 3602A. FDA's guidance document contains instructions on how to fill out the form.

To qualify for a first-ever application waiver of fees, neither an applicant nor any of its affiliates must ever have submitted a premarket application.


Read more:

Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification


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