CDRH Industry: Medical Device Export Certificates: Revised FDA Fees In Effect Today

The FDA’s revised fees for medical device export certificates take effect today. More information about the revised fees is available in the Aug. 19, 2015, Federal Register (FR) Notice.

As we previously communicated, this is the second time the FDA has changed the fees for these certificates since the start of the export certification program in 1996. Since the last fee change in February 2003, the FDA's costs to process medical device export certificates have increased. Because of this, the agency is revising the formula used to calculate the number of original and subsequent device export certificates issued and raising the fee for subsequent certificates. These changes are necessary to ensure that the program remains self-sustaining.

More information about exporting medical devices and the fees for export certificates for all FDA-regulated products are available on the FDA’s website.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health