2016-02878: Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
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The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
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