GLOSSARY: Medical Device

The term Medical Device refers to any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term "devices" also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions. There are three classes of medical devices: Class I (General Controls which include registration of manufacturers, recordkeeping and labeling requirements, compliance with GMPs), Class II (Special Controls which includes performance standards, post market surveillance, and patient registries) and Class III (Premarket Approval which includes implanted and life supporting or life sustaining devices).