Elusive Hierarchy of Risk

FDA challenged to find workable definition of risk for in vitro diagnostics

FDA's decision to regulate allin vitro diagnostics leaves it with the problem of figuring out how to do so in a way that will protect patients while not stifling innovation. The agency has proposed basing the level of regulation on the amount of risk posed by individual tests, but it was clear at a two-day public meeting last week that it will be difficult to garner a consensus on a workable definition of risk.

While risk or lack thereof might be clear at the far ends of the spectrum, the question was what to do about the large gray area in between. The natural tendency of regulators would be to err on the side of tighter regulation over more of the gray, but that would almost certainly reduce incentives to develop new tests. So how risk is defined and how high the hurdles will be for medium-risk tests will determine the makeup of the future IVD catalog.

While stakeholders at the meeting were generally reluctant to provide their own definitions of risk beyond vague outlines, their calls for next steps revealed their biases.

The IVD community is broadly divided into two groups. IVDs that are developed and performed in a single laboratory are considered laboratory-developed tests (LDTs) and currently do not require FDA clearance or approval for marketing.

IVDs that are manufactured in one place and

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