In Vitro Diagnostics Firms Frustrated By FDA Delays

Sidebar: In Vitro Diagnostics (IVD) industry -- more information Manufacturers of devices that test fluids or tissues outside the body say the agency's excessively high standard hinders innovation. Photo: Feit's Photography MAJOR BLOW: National Medical Device Coalition’s Wayne Barlow says delays in FDA approval devastate small companies. The in vitro diagnostics (IVD) industry has long been frustrated by lengthy delays in the United States Food and Drug Administration (FDA) product-appr

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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 ...

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