fda certification is a form of "approval" for the type of medical resource they provide, so "approval" is a very applicable term in this situation. in fact, the clearance process is "approval" for products and technology. "fda approval" is usually affiliated and best known as a term to describe a drug or treatment but the process for medical technology to gain "approval" is exactly what the company applied for and were "approved" with a "clearance" to sell. you are the one who needs to do your "dd" on how the fda works and the various "approval" process for different types of medical and health-related resources that are used and sold in this country. igmb is going to .25-.50 soon.