Export Certificates for Electronic Products
The United States does not provide export certificates for the radiation safety of electronic products. The export certificate provisions of the Federal Food, Drug and Cosmetic Act [21 U.S.C. 381(e)(4)] is only applicable to a drug, animal drug, or device. Export Certificates for devices are available for electronic products that are also devices; however, the certificate only addresses compliance with medical device provisions of the Federal Food, Drug and Cosmetic Act.
The FDA Radiation-Emitting Products web site contains all the relevant information on FDA’s regulation of manufacturers of electronic products.
In the past there has been some confusion regarding FDA regulations and approval of electronic products for radiation safety issues. The document, Getting Your Product to Market (FAQs) answers these questions. For example:
“Q19) How long does it take for CDRH to approve my product after a report receives an accession number?
A) CDRH does not approve electronic products that emit radiation. CDRH does not have the authority, nor does any other federal agency, to approve the radiation safety of an electronic product that emits radiation. If CDRH has not contacted you about your report, it means that we have not identified any significant deficiencies with the report or questions about your product.
Q22) Does FDA approve the certification of my product?
A) No. Certification is a manufacturer’s statement that its product complies with the applicable standard. The manufacturer is responsible for assuring the certification (21 CFR 1010) that a product complies with an applicable standard is true to the best of its knowledge. This statement of certification must be based on a quality control and testing program which can demonstrate that each product manufactured complies with the applicable standard.
Note: The only routine communication sent by CDRH regarding your reports is an acknowledgement of receipt (see Q12). Only manufacturers with safety issues or potential safety issues receive letters from FDA.
Additionally, some countries require a certification that food passing through a cabinet x-ray system has not been adversely affected. FDA’s Frequently Asked Questions on Cabinet X-ray Systems addresses the issue of security x-ray systems and food safety:
“ Q8: Is it safe to eat food, drink beverages, use medicine, or apply cosmetics if any of these products have gone through a cabinet x-ray system?
A8: There are no known adverse effects from eating food, drinking beverages, using medicine, or applying cosmetics that have been irradiated by a cabinet x ray system used for security screening.
The radiation dose typically received by objects scanned by a cabinet x-ray system is 1 millirad or less. The average dose rate from background radiation is 360 millirad per year. The minimum dose used in food irradiation for food preservation or destruction of parasites or pathogens is 30,000 rad.
For more detailed information on radiation used for food inspection or food treatment, see Title 21 CFR 179, www.FoodSafety.gov, contact FDA’s Center for Food Safety and Nutrition, or contact the United States Department of Agriculture Food Safety Inspection Service.”