Electronic & Radiological Devices | Record Keeping

FDA regulations require radiation emitting electronic product manufacturers (and importers) to develop and maintain record keeping systems which contain certain manufacturing, testing and distribution records. These records are required so that FDA has the ability to determine, through a records review, that the manufacturer or importer is fulfilling its obligations of ensuring electronic products that emit radiation are properly certified and they are manufactured according to a manufacturing process that ensures compliance with performance standards; and the companies are providing adequate documentation regarding use, repair, assembly, and warnings related to their radiation emitting electronic products.

FDAImports.com, LLC has former FDA officials who bring unique expertise and experience to assist clients who manufacture, distribute, and import electronic products in the U.S. which are subject to FDA’s electronic product performance standards and product reporting requirements. These experts in the area of FDA law and regulation governing electronic products enable clients of FDAImports.com, LLC to properly prepare for and respond to FDA records requests, avoiding costly delays of imported electronic products at the border or U.S. ports of entry.

Electronic Product Performance Standards and Manufacturer Certifications

Under U.S. Federal law and FDA regulation, the manufacturer and importer are held responsible for producing and importing electronic products that do not unnecessarily emit hazardous radiation and for complying with the general electronic product regulations. All products with an applicable FDA electronic product performance standard must comply with the standard before they are imported into the U.S. FDA does not recognize regulatory approvals from other countries or other organizations.

Once assured that an electronic product does not unnecessarily emit hazardous radiation, the electronic product manufacturer or importer may sell the product in the U.S. However, the electronic product importer and manufacturer must first abide by any applicable federal radiation safety performance standard. Doing so includes ensuring that: 1) the electronic product meets the specific requirements of the FDA performance standard; 2) the electronic product manufacturer has established a quality control and testing program capable of proving the product is manufactured in accordance with the applicable electronic product performance standard; 3) the manufacturer or importer has verified that the electronic product bears certification and identification information, which must be permanently affixed to or inscribed on the electronic product; and 4) the manufacturer’s certification is based on an adequate quality control and testing program.

The Rad Health Act states that any electronic product importer or manufacturer responsible for an electronic product that is subject to a performance standard must provide to its U.S. distributors or U.S. dealers a certification that the electronic product meets all applicable performance standards. The electronic product certification is made a part of the electronic product performance standard.