A Quick Guide to The FDA Classification of Medical Devices

Before launching any product in the market, it is important to have a fair understanding of the product classification. Not only will this invaluable knowledge help in assessing the preparation required before the product is valid to be sold in any given market, but it will also help in establishing what is required during product development and design controls.

Most importantly, it will enable us to determine the cost of launching the product in the market and estimate the amount of time required for the launch. The same theory applies to a Medical Device product. In this article, we'll discuss how the US FDA's Center for Devices and Radiological Health (CDRH) classifies this product under different categories.

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