On a fairly regular basis I receive an inquiry on my desk here at TSI Global Consulting from an importer that is seeking information on import requirements for specific products. Did you know that U.S. Customs provides a valuable source called Importing into the United States: A Guide for Commercial Importers? The guide provides a thorough technical overview of US requirements and required declarations for importing a wide range of products into the United States. For example, did you know:
The following products are subject to the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C—Electronic Product Radiation (formerly called the Radiation Control Health and Safety Act of 1968):
• Television products that incorporate a cathode-ray tube,
• Cold-cathode gas-discharge tubes,
• Microwave ovens,
• Cabinet and diagnostic x-ray equipment,
• Laser products,
• Ultrasound physical therapy equipment,
• Cellular and cordless telephones,
• Other electronic products for which there are radiation-performance
An electronic product: (a) for which there is a radiation performance standard, and (b) that is imported for sale or use in the United States may only be imported if a declaration (Form FDA 2877) is filed with each importer’s entry. Form FDA 2877 is available from the:
Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 20850.
The declaration must describe the product’s compliance status. The importer must affirm that the product was:
• Not subject to a standard (e.g., manufactured prior to the effective date of the federal standard); or
• Complies with the standard and has a label affixed by the manufacturer certifying compliance; or
• Does not comply but is being imported only for research, investigation, study, demo, or training; or
• Does not now comply with the standard, but will be brought into compliance.
The provisions of the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C—Electronic Product Radiation—apply to electronic products manufactured in the United States as well as to imported products.
For details on import requirements for other products consult this guide or contact our office for a product-by-product import review and analysis which we will provide via issuance of an advisory note.