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  1. Industry (Medical Devices)

Letter Regarding Removal of Notary Block on Export Certificates

Dear FDA CDRH Export Certificate Applicant,

Effective March 1, 2014, the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), will immediately discontinue notarizing FDA CDRH export certificates. FDA’s procedural change will affect the following export certificates: Certificate to Foreign Government, Certificate of Exportability, and Non Clinical Research Use Only Certificate.

Even though FDA is not required to authenticate or notarize export certificates, we have been providing these for articles that may be exported from the United States under 21 United States Code (USC) 381(e).   FDA export certificates include the signature of an FDA official and an embossed Department of Health & Human Services (DHHS) federal seal. These officially signed and embossed FDA export certificates are considered official and authentic documents that do not require further verification or authentication. 

The U.S. Department of State, Office of Authentication, provides both Authentication and Apostille Certificates for a variety of documents to individuals, institutions, and government agencies. Should a country or economic area require United States Federal authentication services, you should contact the Office of Authentications, U.S. Department of State, located at 600 19th Street, NW, Washington, DC 20006 or at their website: http://travel.state.gov/content/travel/en/legal/travel-legal-considerations.html

For more information about FDA’s CDRH export certificate program, please visit our webpage at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ImportingandExportingDevices/ExportingMedicalDevices/default.htm

Please disseminate this procedural change to other officials within your organization, as well as the foreign government entities whom you supply. 

Thank you in advance for your cooperation.

Sincerely,

Steven D. Silverman
Director, Office of Compliance
Center for Devices and Radiological Health

 
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