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). Manufacturers of radiation-emitting electronic products which are also medical devices are subject to both the EPRC and Medical Device authorities of the FD&C Act.
What is a corrective action?
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.
What happens when an electronic product is found to be defective or fails to comply with a radiation safety performance standard?
When a manufacturer becomes aware that its electronic product has a radiation safety defect or fails to comply with an applicable federal radiation safety performance standard, it is required to immediately notify FDA. Similarly, when FDA discovers a radiation safety defect or failure to comply with a performance standard, FDA is required to notify the electronic product’s manufacturer.
After this immediate notification has occurred, the manufacturer is required to notify purchasers, dealers, and distributors of the defect or failure to comply. Manufacturers may be required to issue further communications if CDRH deems the content of such initial notice to be insufficient to protect public health and safety.
Manufacturers are also required to submit a corrective action plan to CDRH for approval. If satisfactory, the Center will approve the corrective action, perhaps with certain conditions, before the manufacturer can implement the recall. These activities are published in the FDA Enforcement Report, which is available to the public.
Note: This database search of corrective actions for radiation-emitting products and devices combines results from two different databases: CDRH Product Code search and the Recalls database. The information search will include:
- relevant performance standard(s) associated with the product, and
- specific performance standard violation(s) identified in the recall.
The two references to the performance standard(s) may not to match exactly because they are from two different data sources that do not track each other.