FDA Seeks Input on Qualifications for Foreign Small Businesses

The FDA is requesting comments on its new information requirements for foreign companies seeking small business status under the Medical Device User Fee Amendments of 2007.

The amendments provide a new way for foreign firms to qualify as small businesses, which pay lower medical device user fees, by allowing them to submit a certification from their national taxing authorities. Previously, if a business could not provide a U.S. income tax return, it could not qualify as a small business and had to pay standard user fees.

Tax certifications must be in English, bear the official seal of the company’s national taxing authority and provide the business’s gross receipts or sales from the most recent year in both the local currency and in U.S. dollars, the exchange rate and the dates during which the reported receipts or sales were collected.

The FDA estimates that each company will spend one hour collecting the information for the certification and that the new requirement will affect approximately 229 foreign businesses.