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Tag: pre-marketing

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.

How to get new medical device approved?

medical device compliance
medical device compliance

If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a rigorous process and there are fees involved as well. Medical devices can fall under three separate classes that are relevant to the FDA compliance approval process, and, in the following, they are explained in much greater detail. Getting a medical device approved can be done a couple of different ways.

Classification

After you put together your creation, you must determine what classification it is. The three classes are simply known as class I, II, and III. What property earns the devices this classification is usually the risk it offers users. The lowest level, class I, is associated with devices that are not harmful to consumers in any way. Tongue depressors and thermometers are both types of class I devices. These have a relatively easy procedure to follow to get approved by the FDA.