Electronic & Radiological Devices

FDA Regulation of Electronic & Radiological Products

The FDA regulates radiation-emitting electronic products whether or not they have a medical purpose. Most people would expect FDA to regulate medical x-ray machines or ultrasound devices found in hospitals, but many do not know that FDA also regulates lasers used in laser light shows, infrared and ultraviolet devices, microwave ovens, and the x-ray machines that screen their luggage when they fly on a plane in the U.S.

FDA gained the authority to regulate all electronic products that emit radiation under the Radiation Control for Health and Safety Act of 1968 (Rad Health Act). The term electronic product “manufacturer” is defined very broadly by the Rad Health Act and includes persons who manufacture, assemble and import electronic products.

FDA regulated electronic products include any manufactured or assembled products (along with any component, part, or accessory of such products) which contain or act as a part of an electrical circuit and emit radiation of any kind. The law was drafted so the FDA could also regulate those electronic products that emit radiation if the radiation source was not adequately shielded. The agency not only has jurisdiction if radiation is accessible or humans are exposed; rather, FDA has jurisdiction if the electronic product produces or generates radiation even if such radiation is inside some sort of shielding.

Many radiation-emitting electronic products are also medical devices. In those cases, the electronic product must comply with both the Rad Health Act and the Food Drug and Cosmetic Act (FDCA) governing medical devices.

Examples of Electronic Products Under FDA Jurisdiction

FDA lists examples of electronic products regulated under the Rad Health Act in its regulations. Here is a sampling of the electronic products regulated by FDA. A more expansive list can be found in FDA’s regulations.

• Television receivers
• Computer monitors
• X-ray machines (including medical, research, industrial, and educational)
• Electron microscopes
• Blacklight sources
• Welding equipment
• Alarm systems
• Microwave ovens (devices that generate microwave power)
• All lasers (including low power lasers such as DVD and CD readers/writers/players) and other light-emitting devices (Infrared and Ultraviolet)
• Ultrasonic instrument cleaners
• Ultrasound machines
• Ranging and detection equipment, such as laser levels

FDA Reports and Requirements

FDA has established electronic product performance standards in its regulations covering several varieties of radiation-emitting electronic products. Companies that manufacture or import electronic products subject to an FDA performance standard are required to submit various electronic product reports, the most basic and essential of which is the Electronic Product Initial Report.

When a manufacturer or importer submits an Electronic Product Initial Report, FDA’s Center for Devices and Radiological Health (CDRH) reviews the electronic product report to ensure the information demonstrates that the manufacturer’s electronic product meets any applicable performance standard and that the process for manufacturing or assembling the electronic product is likely to repeatedly produce complying electronic products. CDRH issues an Accession Numbers to the manufacturer that submitted the electronic product report, and that Accession Number is necessary for importing electronic products into the U.S.

Accession numbers are unique FDA identifiers for electronic product reports found in FDA’s radiation-emitting electronic product database. 

FDA requires importers to provide the Accession Numbers on Form 2877. This is the one assigned by FDA to the manufacturers who made the imported electronic products. FDA import entry reviewers, investigators, and compliance officers use it to confirm that a foreign manufacturer or assembler has at least complied with the most basic FDA regulations governing electronic products: the filing of the electronic product report for the FDA review.

Accession numbers are proprietary information only known to FDA and the company that originally filed the report. As such, there is no public database where you can simply look up the accession numbers for products you are importing. This means that you must ask the manufacturer to reveal their accession numbers to you when FDA demands it upon entry into the United States.

There are also specific certification and labeling requirements that apply to electronic products, and the user manual is a critical piece of information for consumers. FDA requires electronic product user manuals to include many specific warnings and declarations, as well as include clear and concise instructions for use.

FDAImports prepares and files electronic product reports for many different technologies and has former CDRH reviewers ready to assist your company in obtaining new Accession Numbers. We can also help manage the importation process and properly respond to FDA notices or correspondence requests.

Record Keeping

FDA regulations require radiation-emitting electronic product manufacturers (and importers) to develop and maintain record-keeping systems which contain specific 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 that they are manufactured according to a manufacturing process that ensures compliance with performance standards. Additionally, they ensure the companies are providing adequate documentation regarding use, repair, assembly, and warnings related to their radiation-emitting electronic products.

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.

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.

Importers of Electronic Products and Electronic Devices

Besides obtaining accession numbers, importers of electronic products must follow other FDA requirements. These include designating a U.S. Agent and meeting FDA reporting and labeling requirements. If the electronic product is also a medical device, there may be other pre-market FDA requirements such as facility registration, device classification, and 510(k) filings. Most medical devices must be manufactured using quality controls (FDA’s QSRs).

If imports are not in compliance, FDA will issue an import detention, which may lead to refusal of the shipment. 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.