Importing and Exporting Electronic Products

Overview

FDA Import Program Overview
This link takes you to a page maintained by the Office of Regional Affairs.

Regulations

• Electronic Products Subject to Import Review by FDA (21 CFR 1005.1 )
• Designation of U.S. Agent (21 CFR 1005.25 )
• Detention and Product Sampling ( 21 CFR 1005.3 )
• Bringing Products Into Compliance (21 CFR 1005.21 )
• Bonds and Fees (21 CFR 1005.23 )
• Exports (21 CFR 1010.20 )
• Export Certificates for Electronic Products

Other Resources

• Importation of Radiation-Emitting Products: Product Code Status Update (October 18, 2006)
• Procedures for Importing Electronic Products which Emit Radiation (PDF)
• Form FDA-2877 Declaration for Products Subject to Radiation Control Standards (PDF)
• Use of FDA-assigned Manufacturer Report's Accession Numbers (PDF)
• Importation of Radiation-Emitting Consumer Electronics for Investigation and Evaluation

Note: Electronic Products that are also Medical Devices are subject to the device provisions of the Federal Food, Drug, and Cosmetic Act. For more information, see Getting to Market with a Medical Device.