The FDA regulates over $1 trillion worth of products which account for 25 cents of every dollar spent annually by American consumers. These products touch the lives of virtually every American every day. It is FDA's job to see that food and cosmetics are safe and that medicines and medical devices are safe and effective and won't do harm. Medical devices are classified and regulated by FDA according to their degree of risk to the public. Devices that are life-supporting, life-sustaining or implanted, must receive FDA approval before they can be marketed. Proven Process Medical Devices is FDA-registered, number 3003174284, and has succesfully undergone a comprehensive FDA audit where the agency has thoroughly exercised our quality system.