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-approval process. Small, entrepreneurial companies whose researchers have developed innovative IVD products are particularly hard-hit by such delays, agency critics contend. While many in the industry agree that the situation seems to have improved within the last year or two, others are clearly dissatisfied, charging that the agency's policies are stifling innovation and keeping valuable products off the market in the U.S. Further improvements may have to wait until Congress enacts a package of comprehensive FDA reforms.

IVDs include all devices...

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