FDA Hikes Fees For Med Device Export Certificates

By Jof Enriquez,
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The United States Food and Drug Administration (FDA) announced recently that it will raise fees for medical device export certificates because of increasing demand for such certificates, as well as rising administrative and payroll costs to run the certification program.

Citing FDA data, Emergo reports that fees for medical device export certificates have not increased since 2003, but the volume of requests for certificates has more than doubled between 2003 (25,236 certificates) and 2014 (52,193 certificates).

"The volume of requests for certificates has increased by 369 percent since FY 1997 and 107 percent since FY 2003. Hence, the export certificate program staff size has increased to accommodate this increased volume of requests," the FDA explained in a notice published in the Federal Register.

Per the FDA Export Reform and Enhancement Act of 1996 (EREA), the Center for Devices and Radiological Health (CDRH) in 2003 had set a maximum fee of $175 for the first certificate, and $15 for all subsequent certificates issued for the same product(s) in the same request, according to the notice.

The FDA may charge a fee of up to $175 if FDA issues an export certificate within 20 government working days of receipt of a request for such a certificate.

However, beginning Sept. 1, CDRH will still charge $175 for an original certificate, but it will raise the fees for subsequent certificates from $15 to $85, according to the FDA.

As previously practiced, CDRH will still allow multiple devices to be included in a single certificate. Per the notice, "The number of original and subsequent device export certificates will be calculated using a revised formula that sets the maximum pages per certificate to 25 pages (the certificate page and a maximum of 24 pages for any attachments). Previously, the maximum number of pages was 50. If the request is more than 25 pages, then the total number of pages created by the request is divided by 25 and that number will be the number of original certificates that will be charged at

$175 and the remaining number of subsequent certificates will be charged at $85 each."

FDA has invited interested parties to submit comments regarding the fee increase for additional review, although the EREA law does not require the agency to do so.

According to the FDA website, FDA export certificates are issued to manufacturers who export products from the United States into another country to satisfy registration and trade requirements. The certificate is considered official assurance that the products entering the foreign country's market meet U.S. regulatory or marketing standards.