FDA classifies radiation therapy system as a Class II medical device
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The Food and Drug Administration (FDA) has issued a final rule classifying fludeoxyglucose F18-guided radiation therapy systems into Class II.
Why it matters: This is a technical regulatory change that makes it easier for companies to bring this specific type of radiation therapy equipment to market by using a standard middle-ground classification rather than more restrictive ones.
Who it affects
- Medical device manufacturers specializing in radiation therapy
This rule was issued by the Food and Drug Administration; readers should consult the Federal Register for the full technical text before relying on it.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document