Adroit Crafting of “Intended Use” Critical – Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words

In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD.

From a regulatory perspective, a key component of the IVD is an intangible attribute -the product’s intended use. It is no exaggeration to say that the regulatory fate of a new IVD may hinge on the few dozen words comprising the proposed intended use.

The intended use also plays a pivotal role in determining the commercial success of the product by establishing the claims that can be made when marketing the product. Thus, IVD companies need to understand what the term “intended use” means and its regulatory significance.

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