Sidebar: In Vitro Diagnostics (IVD) industry -- more information
IVDs include all devices that test body fluids or tissues to detect, diagnose, and manage medical conditions. They range from the automated clinical chemistry analyzers used in hospitals to simple home pregnancy tests. According to the Washington, D.C.-based Health Industry Manufacturers Association (HIMA), in 1995 the total value of the U.S. IVD industry's products was $8.9 billion.
Regulation of the industry began with the passage of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. In this legislation, IVDs were lumped together with implantable devices such as cardiac pacemakers. The categorization has been a cause of consternation for industry ever since.
"In vitro diagnostics are products that are used outside the body," explains Carolyn Jones, HIMA's director of technology and regulatory affairs. "From our perspective, they don't pose the same risk as an implantable device. But FDA ...
