Electronic & Radiological Devices | Product Reports
FDA has established a number of different kinds of required electronic product reports applicable to various electronic products. When reviewing imported electronic products, FDA will search its data systems to ensure all required electronic product reports and manufacturer certifications are present and up to date. If they are not, FDA will issue an FDA import detention, which may lead to an FDA import refusal of the shipment. FDA import refusals will trigger Customs to issue a demand for redelivery for the electronic product shipment and will require the importer to export or destroy the electronic products. This is a very expensive outcome, and it can be avoided by simply preparing and filing the correct FDA electronic product reports and obtaining a valid Accession Number from FDA prior to importing electronic products into the U.S.
For most foreign electronic product manufacturers, the point of filing an electronic product report with FDA is to obtain the FDA Accession Number, which is necessary in order to import electronic products into the U.S. However, FDA’s purpose for its regulation of radiation emitting electronic products is to prevent unnecessary or accidental exposure to or release of radiation due to the electronic product use, defects or failures.
Before exporting radiation emitting electronic products to the United States, the manufacturer must first submit its electronic product reports to FDA. Once the acknowledgement letter and Accession Number are assigned, the manufacturer will then have the evidence needed to prove that FDA received the electronic product report. For foreign-made and foreign-assembled radiation emitting electronic products, the FDA will require the importer to provide the manufacturer’s FDA Accession Number to release the electronic product into commerce.
FDAImports.com, LLC assists U.S. importers and foreign manufacturers and assemblers of radiation emitting electronic products by preparing, submitting and prosecuting their FDA electronic product reports and obtaining an FDA Accession Number for them.
In addition, FDAImports.com, LLC manages the importation process and properly responds to FDA notices or correspondence requests from FDA. FDAImports.com, LLC literally shows The Way Through the electronic product reporting, labeling, certification, and importation process for electronic product manufacturers of all sizes utilizing all types of technologies.