FDA reclassifies radiation therapy marking devices
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Table of Contents
The FDA has changed how it regulates a specific type of medical tool called a radiation therapy marking device. These are powered tools used to deliver color onto a patient’s skin to help guide radiation therapy treatments.
Why it matters: This is a regulatory change that lowers the barrier for companies wanting to sell these specific marking tools. By moving the device from Class III to Class II, the FDA has made it easier and faster for future manufacturers to enter the market without undergoing the most rigorous level of federal review.
Who it affects
- Medical device manufacturers making radiation therapy equipment
This information comes from a final rule issued by the Food and Drug Administration; readers should consult the Federal Register for full technical details and safety requirements.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document