Recent regulatory developments continue to signal that, barring congressional or judicial intervention, the U.S. Food and Drug Administration (FDA) intends to bring many more diagnostic test products and systems under regulation as “medical devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). This move may have broad implications for companies in Florida and elsewhere that develop or manufacture diagnostic test products and systems that fall within FDA’s revised definition of In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). IVDMIAs include many genetic-based tests as well as many diagnostic test systems/services developed and marketed by clinical laboratories. While many such products are on the market or currently under development, as a matter of traditional FDA enforcement policy very few have been regulated as medical devices to date.
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