Devicemakers to Shell Out More for Export Certificates

August 21, 2015

Medical devicemakers in the U.S. will have to pay more for their follow-on export certificates. A lot more.

In an Aug. 19 Federal Register notice, the FDA says it is raising the price of subsequent export certificates from $15 to $85 — an increase of about 466 percent.

This marks the first time that costs for these types of certificates, which are issued for the same products as part of the same request, have gone up since 2003.

“These changes are necessary to ensure that the program remains self-sustaining and to cover FDA’s increased costs, which are currently being covered by appropriated funds,” according to the notice. The total cost of the export certification program for devices in FY 2014 was $5.7 million.

As the agency notes, the volume of certificate requests has grown 369 percent since FY 1997, when 11,140 were issued. In FY 2014, 52,193 were issued. Adding to the strain is that devicemakers are permitted to include multiple devices on a single certificate, rather than having to file separate ones.

While the FDA will continue to allow multiple devices to be included on a single certificate, it has cut the maximum number of pages from 50 to 25. That number includes the certificate page and a maximum of 24 more to allow for any attachments. The notice provides additional details on how the agency will determine the total cost of certificates.

Original certificates will continue to cost up to $175. The increased fees for subsequent certificates take effect Sept. 1.

Read the Federal Register notice at www.fdanews.com/082415-export-certificates.pdf. — Elizabeth Hollis