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FDA seeks public comment on user fee form for small business

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 28, 2008

The FDA is seeking public comments on its Form 3602A that foreign businesses need to complete to qualify as small businesses. The form will allow foreign businesses to qualify for a much lower medical device user fee rate under the Medical Device User Fee Amendments of 2007.

According to the notice in the January 15 Federal Register, comments should be submitted by March 17. The FDA is looking for feedback on the usefulness of the form, the FDA's estimated burden for completing the form, and ways to improve the form and ease efforts to complete and submit it.

The new form alleviates the need for a foreign business to submit a US income tax return showing gross receipts and sales below $100 million. Many foreign businesses couldn't provide a US income tax return and thus had to pay higher user fees. The new form allows foreign businesses to submit a National Taxing Authority Certification concerning gross receipts and sales in place of the income tax return.

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