Radiation-Emitting Products
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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
- Letter to Industry about Import Entry Review Process (September 6, 2011)
- 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.
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