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FDA rejects proposed changes to Foreign Small Business Certification

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 21, 2008

The FDA submitted an unchanged Foreign Small Business Qualification Certification, Form FDA 3602A form for review and clearance by the Office of Management and Budget on April 10.

&The form qualifies foreign small businesses for lower fees under the Medical Device User Fee Amendment. In the Federal Register notice, the FDA rejected two suggested changes submitted by commenters following the January 2008 publication of the draft form

One comment suggested the FDA only require small business qualification be demonstrated using the form every three to five years. The commenter argued this would save both companies and the FDA time and money spent on paperwork. The FDA rejected the suggestion, however, stating the law requires small business qualification be demonstrated based on financial information for the “most recent” year. It would be impossible to confirm that a small business’s status remained unchanged for more than a year, the FDA said.

The second comment noted foreign small businesses may face difficulties getting foreign governments to complete the tax certification information on the FDA’s Form 3602A. Therefore the commenter suggested allowing foreign businesses to submit tax reports or income statements from the foreign countries with English translations and exchange rates determined by the small business applicant. The FDA rejected this idea by again noting it did not have the power to modify the law, which requires the FDA certification form be completed, signed, and bear the foreign taxing authority’s seal.

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