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FDA releases guidance on qualifications for small businesses

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 11, 2008

Small business can pay substantially smaller user fees for medical devices, but before a business can take advantage of those reductions, it must be certified as a small business. Recent FDA guidance will help businesses determine whether they qualify.

Businesses with gross receipts or sales of no more than $100 million, including sales by affiliates, in the most recent tax year may qualify as small businesses. Companies with gross sales of no more than $30 million can qualify for a waiver of their first-ever pre-market application.

A company that believes it qualifies as a small business should:

• Submit an FY 2009 MDUFMA Small Business Qualification Certification (Form FDA 3602) and copies of its most recent federal income tax returns directly to the FDA, if headquartered in the United States

• Complete sections I and II of an FY 2009 MDUFMA Foreign Small Business Qualification Certification and submit it and supporting evidence of qualification to its national taxing authority, if headquartered outside of the United States

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