FDA classifies radiation therapy marking devices as Class II
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This rule puts radiation therapy marking devices into FDA Class II with special controls. That means manufacturers can market these devices through the usual 510(k) path, but they must meet testing, labeling, sterility, software, and electrical safety requirements designed to reduce risks like infection, needle-stick injuries, device failure, and skin reactions. The rule matters for medical device makers, importers, and compliance teams because it spells out the exact controls a device must meet to stay out of Class III. It also adds a new regulation at 21 CFR 892.5785 and makes clear that reusable needles and devices meant for diagnostic, therapeutic, or cosmetic use are not covered.
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Key Changes
- Reclassifies radiation therapy marking devices as FDA Class II with special controls
- Requires specific testing and labeling for sterility, software, electrical safety, and contamination risks
- Adds new codified regulation at 21 CFR 892.5785 and keeps the devices subject to 510(k) review
Obligations
What this law requires
Manufacturers of radiation therapy marking devices must classify their product as Class II and comply with the FDA special controls in 21 CFR 892.5785 to avoid automatic Class III treatment.
Manufacturers of radiation therapy marking devices must ensure their devices comply with the FDA special controls for Class II devices, including design verification and validation demonstrating colorant compatibility, reproducible delivery, visible duration on skin, needle penetration accuracy, cross-contamination protection, cleaning/disinfection adequacy, sterility of patient-contacting components, electrical safety, electromagnetic compatibility, shelf-life performance, and software verification/validation/hazard analysis.
Manufacturers must document performance data showing that the indicated colorant is compatible with the device and delivery method, that the device reproducibly delivers the colorant to the stated specifications, and that compatible colorants remain visible on the skin for the intended duration.
Manufacturers must support design verification and validation with performance data showing that the indicated colorant is compatible with the device and delivery method, the device reproducibly delivers the indicated colorant as specified, and the colorant remains visible on skin for the stated duration.
Manufacturers must generate performance data demonstrating accurate and reproducible needle penetration depth, protection against cross-contamination (including fluid ingress protection), adequate cleaning and disinfection instructions for reusable components, and sterility of all patient-contacting components.