FDA Import Program Overview
This link takes you to a page maintained by the Office of Regional Affairs.
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.
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 1005.3) Bonds and Fees (21 CFR 1005.23) Exports (21 CFR 1010.20) Export Certificates for Electronic Products
Letter to Industry about Import Entry Review Process (September 6, 2011) Importation of Radiation-Emitting Products: Product Code Status Update Procedures for Importing Electronic Products which Emit Radiation(PDF - 632KB)
- Declaration for Imported Electronic Products Subject to Radiation Control Standards - Form #2877 (PDF - 670KB)
Use of FDA-assigned Manufacturer Report's Accession Numbers(PDF - 133KB) Imports of Radiation-Emitting Consumer Electronics for Investigation