My organization filed a Form 990, Return of Organization Exempt from Income Tax. Do I still need to qualify as a Small Business?

Yes. The FD&C Act does not exempt you from medical device user fees or grant you
automatic small business status simply because you are exempt from Federal (U.S.) income
tax. You are subject to the same “gross receipts or sales” thresholds as other applicants. You
should report your Total Revenue (line 12 of Form 990) as your “gross receipts or sales.” In
addition, include a signed copy of your Form 990.