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CDRH Activities

• Exporting Medical Devices
• Importing Medical Devices
• Mutual Recognition Agreement (MRA)
• Third party review
• Medical devices and radiation-emitting electronic products International activities
• STED Initiative

FDA Resources

• International cooperative agreements
• FDA in the International arena
• Device Advice
• Reporting problems with Medical Devices

Who to Contact

• International assistance contacts
• General contact information

Guidance Documents

• Third party programs and MRA guidance
• Background information for International officials

Resources Outside FDA

• International organizations and Foreign government agencies
• Non U.S. medical device regulators
• Global Harmonization Task Force
• Standard organizations
• Other U.S. agencies