Aug 6, 2012

The US Food and Drug Administration has opened small business qualification to foreign companies--including those that have not submitted US income tax returns--and also eliminated establishment registration fee discounts for small businesses as part of the agency’s updated Medical Device User Fees for 2013.

Reduced fees for medical device manufacturers qualifying as small business remain in place for other FDA reviews and functions such as 513(g) requests for classification. (The complete 2013 FDA reduced-fee schedule for small businesses is available in the FDA’s Medical Device User Fee guidance for small businesses.)

For the 2013 fiscal year, both US-based and foreign medical device manufacturers may qualify for small-business discounts if their reported gross sales totaled $100 million or less for the most recent tax year. Firms based in the US should submit a 2013 MDUFA Small Business Qualification Certification as well as copies of their most recent income tax returns to the FDA. Foreign manufacturers should submit evidence of qualification to their national taxing authorities in order to obtain National Taxing Authority Certification, which should then be sent to the FDA along with 2013 MFUDA Small Business Qualification Certification.

By opening up its small business qualification to foreign medical device manufacturers that have no US income tax returns on file, the FDA should attract more smaller-tier companies that would have otherwise found registration costs prohibitive to seek market authorization in the US.


  • Stewart Eisenhart