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, it will also help in establishing what is required during product development & design controls.
Most importantly, it will enable us to determine the cost of launching the product in the market and estimating the amount of time required for the launch. The same theory applies for a Medical Device product. In this article, we’ll discuss as to how the US FDA’s Center for Devices and Radiological Health (CDRH) classifies this product under different categories.
