Radiation Marking Devices Get FDA Class II Nod
Published Date: 4/30/2026
Rule
Summary
The FDA is officially putting radiation therapy marking devices into Class II, meaning they’ll have special safety rules but less red tape than before. This change helps make sure these devices are safe and effective while making it easier for patients to get new, helpful tech. The new rules took effect April 30, 2026, but the classification has been in place since December 2021, so manufacturers should already be on board.
Free Policy Watch
New rules are filed every week. Most people never see them.
Pick a topic. PRIA watches every federal rule and tells you when one hits your household.
Pick a topic to get started
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Easier Patient Access to Marking Devices
The FDA has classified radiation therapy marking devices as Class II with special controls, effective April 30, 2026, and noted the classification has applied since December 10, 2021. The agency says this change reduces regulatory burdens and will help patients get access to new marking technologies that guide radiation therapy.
Manufacturers Gain 510(k) Pathway Option
By classifying this device type via the De Novo process, FDA said the radiation therapy marking device can serve as a predicate for future devices, allowing other sponsors to use the less-burdensome 510(k) process. The order also states these devices remain subject to premarket notification requirements under section 510(k).
New Safety and Labeling Requirements for Devices
The rule sets specific special controls manufacturers must meet, including biocompatibility testing, sterility and shelf-life testing, software validation, electrical safety testing, and labeling that includes operation, reprocessing instructions for reusable components, disposal instructions, and shelf life for sterile parts. These controls are required for the device to fall within Class II and to provide reasonable assurance of safety and effectiveness.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Take the PRIA Score to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in