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U.S. Department of Health and Human Services

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Are medical devices regulated for non-medical reasons?

Yes, if the device is an electronic product that emits (or if unshielded, would emit) electronic product radiation. Manufacturers of such electronic products should be aware that certain radiation protection requirements and recommendations exist under 21 CFR Subchapter J - Radiological Health.

Medical devices are just a subset of electronic products that may have general regulatory provisions. Some electronic product manufacturers have specific performance, reporting, and recordkeeping standards that must be met before and after their electronic products enter into commerce. Examples of the types of electronic product radiations that are regulated include x-rays and other ionizing radiation, ultraviolet, visible, infrared, microwave, radio and low frequency radiation, coherent radiation produced by stimulated emission, and infrasonic, sonic, and ultrasonic vibrations.

Specific electronic product performance standards exist for medical device electronic products that emit (or would emit) such radiation, for example; x-ray machines, accelerators, neutron generators, biochemical and medical analyzers, medical laser products, sanitizing and sterilizing devices, diathermy units, medico-biological heaters, cauterizers, biomedical analyzers, and ultrasound. Examples of other electronic products are microwave ovens, tanning beds, radar devices, alarm systems, non-medical lasers, etc.

Go to the FDA Basics Radiation-Emitting Products page for more information.

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