Why POM is a Class II Approved Medical Device of the FDA
September 23, 2022
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One of the many responsibilities of the FDA is to advance public health by helping speed-up medical innovations that are safe, effective and affordable. Just like pharmaceuticals, medical devices are required to conduct extensive clinical trials and studies before submitting an application to the FDA.
If the research substantially shows a device’s safety, efficacy and value to advancing medical practice, it then goes through a classification study during the FDA’s Premarket Approval Process (PMA). This process involves evaluating the device for its scientific evidence showing greater benefits to patient health while outweighing the possible risks of its use. Also, this process allows for a medical device to be assessed on an individual basis, rather than using data from a similar device to help evaluate its safety and effectiveness.
The POM has exceeded the standards of the PMA, and is a Class II approved device of the FDA, meaning it is in the lowest risk category of risk for medical devices.