The Radiation-Emitting Electronic Products Corrective Actions and Recalls includes electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product
The Center for Devices and Radiological Health (CDRH) regulates manufacturers of radiation-emitting electronic products under the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. EPRC authorities apply to manufacturers of radiation-emitting electronic products used both in non-medical applications (e.g., laser engravers, microwave ovens, security x-ray scanners) and medical applications (e.g., ultrasound therapy, diagnostic x-ray devices, LASIK).
Corrective actions defined under EPRC are similar to Corrections and Removals defined in the medical device provisions of the FD&C Act, both of which are commonly known as “recalls.” Manufacturers are required to perform corrective actions on their electronic products when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.
When implementing corrective action, a manufacturer is required to either:
repair the products,
replace the products, or
refund the cost of the products to the purchasers (and reclaim the products) without charge to the owner of the electronic product.