4 Regulatory Challenges Facing IVD Companies Today

In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty.

Many regulatory challenges for IVD companies relate to issues that are evolving and changing. Even where there appear to be clear regulatory requirements, it is not yet knownor not always reasonably foreseeablehow FDA will implement those requirements. In this article, we will examine four significant regulatory challenges facing IVD companies today.

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