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.
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The CEO allegedly falsely told investors that the company was closing in on FDA clearance for a rapid-detection COVID-19 test.
The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.
The US Department of Health and Human Services is offering some legal protection to developers of devices and diagnostics for use in the fight against the novel coronavirus.