Radiation Control for Health and Safety Act of 1968 (RCHSA)

Foreign manufacturers that export to the U.S. electronic products (medical and non-medical) that emit radiation are subject to the requirements of the FDA's Electronic Product Radiation Control provisions (added to the Food Drug & Cosmetic Act by the Radiation Control for Health & Safety Act of 1968).

These requirements include performance standards, labeling, and submission of radiation safety product reports. When manufacturers submit radiation safety product reports, the reports are entered into a database and assigned an “accession number.” Generally, importers may submit radiation safety product reports on behalf of manufacturers.

The purpose of FDA’s regulation of radiation emitting products is to prevent unnecessary radiation exposure when using and operating such products. There are specific requirements under the RCHSA that apply to all radiation emitting electronic products. If the product is also a medical device, then it must also comply with the medical device requirements of the Food Drug & Cosmetic Act (FDCA).

FDAImports.com consultants and affiliated attorneys can assist companies with all aspects of FDA's radiation control regulatory authority.

As discussed below, FDA expects importers of electronic products to provide the manufacturer's “Accession Number” in the import entry record, as well as a statement that the product complies with any applicable performance standard and the manufacturer has certified the product to the standard. FDA routinely detains and refused shipments of imported electronic products simply because the importer failed to provide the required information -- even though the manufacturer, importer and product are all in compliance with the relevant statutes and regulations. Because of the high value of such shipments, it is not uncommon for an importer to distribute the product before FDA has released it. Once refused, Customs will issue a demand for redelivery of the shipment. Because the products have been shipped already, they are not available for export (or, even less likely, destruction) so Customs will proceed to a claim for liquidated damages, sometimes in excess of $750,000.

FDAImports.com affiliated attorneys have successfully obtained cancellation of such Customs claims based upon FDA's application of its regulatory authority.

Definition of Electronic Product Radiation

Under the RCHSA, the term “electronic product radiation” includes all ionizing and non-ionizing electromagnetic and particulate radiation. It also includes infra-sonic, ultra-sonic, and sonic waves. When an electronic product emits any of these forms of radiation, FDA will regulate the product irrespective of whether it is intended for medical or health purposes.

Under the RCHSA the term “electronic product” includes any product which has with in it or is a part of an electronic circuit that also emits (or it would emit except for effective shielding or other controls) electronic product radiation. The definition also includes components, parts, or accessories of a completed product.

The fact that a product is shielded, preventing it from emitting radiation, does not remove it from FDA's radiation emitting product regulations.

Examples of Electronic Products Under FDA Jurisdiction

FDA lists examples of electronic products regulated under the RCHSA in its regulations. Any of the examples could be intended for a medical purpose and could be regulated by FDA as medical devices also. To give an idea of how broad FDA’s jurisdiction is over electronic products and radiation emitted from electronic products, we have included a sampling of the articles regulated by the agency below. A more expansive list can be found in FDA’s regulations.

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

The term “manufacturer” is defined very broadly by the RCHSA, and includes persons who manufacture, assemble and import electronic products

Many radiation-emitting products are not medical devices. However, if the labeling of a radiation-emitting device makes any medical claims, FDA will be regulate the device as a medical device under the FDCA in addition to its electronic product regulations. FDA establishes performance standards for many types of electronic products. Before an electronic product that is subject to a performance standard can be distributed in U.S. commerce, certain reports, tests, and certifications must be completed.

FDAImports.com consultants and affiliated attorneys can assist companies in ensuring their electronic products comply with FDA's applicable performance standards.

Electronic Products Labeling and Certification

All electronic products must bear certain statements in labels and manuals, depending upon the product and the manner in which FDA regulates it. The RCHSA states that any manufacturer of an electronic product that is subject to a performance standard must provide to its distributor or dealer a certification that the electronic product meets all applicable performance standards. The certification is made a part of the performance standard for the actual product.

FDAImports.com consultants and affiliated attorneys can assist companies in ensuring all electronic products comply with FDA labeling and certification requirements.

Record and Reporting Requirements by Product

Certain electronic products require the submission of product reports to FDA and the retention of certain manufacturing, testing and distribution records. The various reports and record retention requirements are established by FDA regulation throughout the RCHSA regulations (generally on a product by product basis). FDA has established a number of different kinds of required reports applicable to various electronic products. When the products are imported, FDA will search its data systems to ensure all required reports and certifications are present and up to date. If not, FDA will refuse the shipment and Customs will require its redelivery and exportation. If the importer fails to export (or destroy) the FDA refused shipment, Customs will issue a liquidated damages claim worth up to three times the invoice value of the refused products.

FDAImports.com consultants and affiliated attorneys can assist importers and foreign exporters of electronic products in managing the importation process and properly responding to FDA notices or correspondence or enforcement actions brought by Customs based upon alleged FDA violations.

Civil Remedies for Violations of Prohibited Acts Under RCHSA

FDA may, through the U.S. Department of Justice (DOJ) file a civil complaint in U.S. District Court to restrain violations of the prohibit acts. In addition, FDA may seek to enjoin dealers and distributors of electronic products from disposing of or further distributing any products that fail to comply with performance standards. FDA is also granted authority to seek civil monetary penalties for certain violations. Civil monetary penalties can be as high as $300,000 for a related series of violations.

FDAImports.com affiliated attorneys can assist in petitioning the government for mitigation or cancellation of FDA penalties.