The US Food and Drug Administration (FDA) has put out an alert to dentists, dental care professionals and veterinarians about hand-held dental X-ray units, saying it “is concerned that these devices may not be safe or effective and could potentially expose the user and the patient to unnecessary and potentially harmful X-rays.”
The release (which is available online here) points out that the FDA is aware of hand-held dental X-ray units that do not meet their requirements being sold online by manufacturers outside the U.S. and directly shipped to customers in the U.S.
“All hand-held dental X-ray units that have been certified by the manufacturer to meet the FDA’s radiation safety standards bear a certification label/tag, a warning label, and an identification (ID) label/tag on the unit’s housing,” the FDA says. “All labels/tags should be in the English language and permanently affixed or inscribed on each product so that they are legible and readily accessible when the X-ray unit is fully assembled for use.”
In order to be legally marketed in the U.S., hand-held dental X-ray units must comply with FDA’s radiation safety and medical device requirements. Manufacturers of these devices must submit premarket notifications for evaluation by the FDA for safety and effectiveness before the product is cleared for sale in the U.S. Manufacturers of these devices are required to register annually with the FDA in addition to other requirements.
The CERTIFICATION LABEL should state: “This product complies with 21 CFR 1020.30 – 1020.31”, “This product complies with 21 CFR Subchapter J” or other similar language.
The WARNING LABEL must be on the x-ray panel of the unit and state these exact words: “This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.”
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