
FDA regulations on hyperbaric medicine
FDA regulations on hyperbaric medicine ensure that treatments using pressurized oxygen are safe and effective. They oversee the devices involved, like hyperbaric chambers, and ensure clinics follow proper standards to prevent harm. The FDA also approves specific uses for hyperbaric oxygen therapy, primarily for approved medical conditions such as certain chronic wounds or decompression sickness. These regulations help maintain quality control, protect patients, and ensure that therapies are based on scientific evidence rather than unproven claims. Overall, FDA oversight aims to promote safe, effective, and reliable hyperbaric treatments within regulated healthcare settings.