What routine requirements apply to manufacturers of radiation-emitting electronic products?
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.
- What products are regulated as electronic products that emit radiation?
- Where can I find more information about a specific type of product?
- What routine requirements apply to manufacturers of radiation-emitting electronic products?
- Does FDA approve radiation-emitting electronic products?
- How does FDA regulate radiation-emitting electronic products?
- What happens when a radiation-emitting electronic product is also a medical device or is used for irradiation or inspection of food?
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- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
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- 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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