Exporting medical devices from the United States often requires a certificate for products regulated by the FDA. An export certificate gives information from the FDA on the product’s regulatory status.  The FDA has revised medical device export certificates fees for the second time since the program began in 1996.   Medical device export certificate processing costs have gone up over the years.  In order to keep the program self-sustaining, an updated formula is being used to calculate the certificates issued and raising the fee for subsequent certificates.  For more information about medical device export certificates:

• Exporting Medical Devices
• Export Certificate Fees
• Federal Register Notice on Medical Device Export Certificates