With FDA registration in medical devices, the food and drug administration established a system of approximately 1700 different generalizing classifications of devices and grouped them into 16 medical features, named in plate form. Each comprehensive type of devices assigns one of three regulation classes, based on the level of control required to ensure the effectiveness and safety of the device.

Device Class and Regulations controls

• Class 1 General Controls
• Class 2 General Controls and Special Controls
• Class 3 General Controls and Pre-Market Approval

The federal food and cosmetic law defines a medical device including an instrument, apparatus, hardware, machinery, any component, part, and accessory.

These;

• It is defined in the national formula booklet and either in the US pharmacopoeia or in any supplement thereof.
• It is intended for use in the diagnosis of disease or in the treatment, alleviation, amelioration or prevention of disease in humans or animals.
• It is designed to affect the structure or any process of the human or animal body, which cannot achieve its primary intended purpose by means of chemical in or on human or animal bodies, and this does not depend on whether it has been metabolized for the attainment of primary intended purposes.