All manufacturers of electronic products are required to notify FDA when they discover their product
- has a radiation safety defect,
- fails to comply with a performance standard, or
- is involved in an accidental radiation occurrence.
Manufacturers of some products are required to keep records and submit reports regarding their products’ technical specifications and quality control programs. Manufacturers of some products are also required to submit annual summaries of radiation safety test results.
Additionally, manufacturers of products with a mandatory radiation safety product performance standard are required to certify that their products comply with the requirements of that performance standard.
View more record and reporting requirements by product.
For additional information, 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?
- Materials from the Webinar on Indoor Tanning: The Risks of UV Radiation
- 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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