Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics

Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.

The rapidly changing landscape around COVID-19 has left little time for federal enforcement actions. But that should shift as the vaccine becomes more widely used in coming months – and as it does, watch for products covered under the PREP Act, diagnostics, and emergency use authorization (EUA) products to come under scrutiny, a panel of attorneys recently said at a conference hosted by the Food and Drug Law Institute.

The Public Readiness and Preparedness (PREP) Act allows the secretary of the US Department of Health and Human Services (HHS)...

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