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

 
• By Shawn M. Schmitt

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.

Pipette adding fluid to one of several test tubes

A new FAQ sheet from the US Department of Health and Human Services (HHS) defends its recent decision to remove Food and Drug Administration oversight of laboratory developed tests, saying the agency “rarely enforced” premarket review of LDTs in the first place.

“FDA will no longer require premarket review of tests developed by a laboratory for use solely within that lab (laboratory...

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