The Problem of Regulatory Uncertainty

IVD manufacturers are accustomed to risk. Taking risks is part of their business. Companies develop plans to identify and mitigate risks, from product development to finished product manufacturing. While risks cannot be eliminated, generally they can be recognized and managed.

One category of risks-regulatory risks – is well-known and can readily be characterized. The U.S. Securities and Exchange Commission filings for IVD companies routinely spell out their regulatory risks. When risks are known and understood, they can often be mitigated.

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