The FDA, for one reason. UVC radiation can cause severe burns (of the skin) and eye injuries (photokeratitis)
"Risks: UVC lamps used for disinfection purposes may pose potential health and safety risks depending on the UVC wavelength, dose, and duration of radiation exposure. The risk may increase if the unit is not installed properly or used by untrained individuals.
- Direct exposure of skin and eyes to UVC radiation from some UVC lamps may cause painful eye injury and burn-like skin reactions. Never look directly at a UVC lamp source, even briefly. If you have experienced an injury associated with using a UVC lamp, we encourage you to report it to the FDA.
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- Some UVC lamps generate ozone. Ozone inhalation can be irritating to the airway.
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- UVC can degrade certain materials, such as plastic, polymers, and dyed textile.
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- Some UVC lamps contain mercury. Because mercury is toxic even in small amounts, extreme caution is needed in cleaning a lamp that has broken and in disposing of the lamp.
A: UVC lamps are electronic products. The FDA regulates electronic products that emit radiation (both non-medical and medical products) through the Electronic Product Radiation Control Provisions, which were originally enacted as the
Radiation Control for Health and Safety Act. Certain electronic products may also be regulated as medical devices. The FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
UVC lamp manufacturers are responsible for compliance with all applicable regulatory requirements, including
Title 21 Code of Federal Regulations (CFR) Parts 1000 through 1004, and section 1005.25 and, as applicable,
21 CFR Chapter I, Subchapter H. The radiological health regulations include reporting of Accidental Radiation Occurrences, notification to the FDA and customers of radiation safety defects, and designation of a U.S. agent for imported lamps. When a UVC lamp is regulated only as an electronic product, there are currently no specific FDA performance standards that apply.
Ultraviolet lamps intended for medical purposes, such as products that disinfect other medical devices or irradiate part of the human body, that meet the definition of medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act also typically require FDA clearance, approval, or authorization prior to marketing."
UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Corona
