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Regulations for Medical Devices in America

Regulations for Medical Devices in America

In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices that are sold in the United States. It also regulates electronic products that emit radiation. These products include lasers, x-rays, ultrasounds, microwaves, and color televisions.

Radiation-emitting Electronic Products

Medical devices are broken down into three classes, Class I, Class II, and Class III. Class I has the least amount of regulatory control and are exempt from having to submit a Pre-market Notification 510(k) for approval. Class II devices; however, require Pre-market Notification 510(k). Class III devices require Pre-market Approval and the approval of two groups.