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
- 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 Standards Form #2877
- Use of FDA-assigned Manufacturer Report's Accession Numbers
- Form FDA 2877 Guidance: Imports of Prototypes (Affirmation A6, May 14, 1997)