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Ex-FDA Commish Warns Of ‘Limbo’ For COVID-19 LDTs Granted Emergency Use Authorization

Gottlieb cautions in tweets that a new policy by the HHS to remove FDA oversight of lab developed tests “is broader than COVID. It covers any LDT”

Executive Summary

Scott Gottlieb took to Twitter on the morning of 22 August to question the wisdom of a move this past week by the US HHS to strip away the FDA’s oversight of laboratory developed tests for the novel coronavirus.

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FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections

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.

FAQ Sheet From HHS Says FDA ‘Rarely Enforced’ Premarket Review Of LDTs

The US HHS defends its recent decision to relieve the FDA from oversight of laboratory developed tests in a new FAQ sheet, saying the agency hardly ever enforced the premarket review of LDTs in the first place.

Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs

Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.

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