FDA has regulatory authority to establish an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As part of this authority, FDA establishes performance standards for radiation-emitting electronic products and takes enforcement action against manufacturers of defective electronic products that emit radiation. When FDA finds a radiation safety problem with an electronic product, we notify the product’s manufacturer.
Manufacturers may respond to FDA’s notice in three ways:
- provide evidence to prove a radiation safety problem does not exist,
- request an exemption from notification of affected persons and provide evidence that there is not a significant risk of injury from the radiation safety problem, or
- submit a corrective action plan to address the safety concern.
If the evidence provided by the manufacturer to demonstrate that the problem does not exist or that there is not a significant risk of injury is inadequate, then the manufacturer is required to submit a corrective action plan. The manufacturer can propose in the corrective action plan to repurchase, repair, or replace the affected products.
For more information, please visit the Radiation-Emitting Products Industry Assistance: Walk-through.
- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
- What products are regulated as electronic products that emit radiation?
- Where can I find more information about a specific type of product?
- What happens when a radiation-emitting electronic product is also a medical device or is used for irradiation or inspection of food?
- Does FDA approve radiation-emitting electronic products?
- What routine requirements apply to manufacturers of radiation-emitting electronic products?
- How does FDA regulate radiation-emitting electronic products?
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- How can I find out how much radiation I receive during an x-ray?
- What should I do before getting a diagnostic medical x-ray?
- What is FDA's role in overseeing and regulating radiation-emitting electronic products?
- What is a radiation-emitting electronic product?
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