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Export Certificate Fees for Medical Devices Increased

Wednesday, August 19, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is increasing the fees it charges for issuing export certificates for medical devices and revising the formula used to calculate the number of certificates issued.

Any person who exports a medical device may request that FDA certify in writing that the device meets certain specified requirements. Provided the device meets those requirements, FDA must issue the certification within 20 days of the receipt of the request.

FDA currently charges $175 for the first certificate and $15 for all subsequent certificates issued for the same product(s) in the same request. However, the costs of the export certification program have grown since those amounts were last adjusted due to the increased volume of requests for certificates and the subsequent increase in payroll costs.

As a result, effective Sept. 1, FDA will increase from $15 to $85 the fee for all subsequent certificates issued after the original for the same product(s) in response to the same request. The fee for issuing each original certificate will remain $175.

FDA will also continue to allow multiple devices to be included in a single certificate rather than requiring that each device have a separate certificate for which a fee is charged. However, the agency is revising the formula by which the number of original certificates and subsequent certificates will be calculated to specify that the maximum number of pages per certificate is being lowered from 50 to 25. As a result, if a request is more than 25 pages, the total number of pages created by the request will be divided by 25 and the resulting number will be the number of original certificates that will be charged at $175, with the remaining number of subsequent certificates charged at $85 each.

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