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Electronic and Radiological Health
FDA is responsible for regulating radiation-emitting electronic products. The agency's goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products.
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The Radiation Control provisions apply to any "electronic product" which is defined as any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation
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contains or acts as part of an electronic circuit and
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emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
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These products can be medical in nature like
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x-ray machines
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ultrasound machines
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fluoroscopy
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dosimeters
They are also non-medical in nature like
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microwave ovens
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television receivers
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monitors (video displays)
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sun lamps
Do you know what products are considered to be electronic and radiological health products by the FDA?
Do you know all of the requirements surrounding these products?
Do you know about the Performance Standards? Are your products subject to the Performance Standards?
Do you know the reporting requirements?
Do you know about FDA's eSubmitter program?
Are you ready for an inspection?
Do you know what records need to be maintained?
Are your products ready for importation into the U.S or exportation?
Are your products on Import Alert? Do you know why and how to get off an Import Alert?