FDA increases fees associated with processing device export certificates

The Food and Drug Administration (FDA) announced this week that it has increased the fee for processing medical device export certificates that have already been requested in the past.

The FDA currently charges up to $175 for certificates to be processed the first time, and this number has not changed. The fee for requesting subsequent documents for the same product, however, has increased from $15 to $85.

The FDA said this change is due to an increase in the costs associated with processing these certificates.

“The volume of requests for certificates has increased by 369% since FY 1997 and 107% since FY 2003,” the  FDA wrote in its Federal Register Notice. “Hence, the export certificate program staff size has increased to accommodate this increased volume of requests.”

These revised fees go into effect on Sept. 1.