Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia

The 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...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news