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HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review

On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests (“LDTs”). These changes resume FDA premarket review of COVID-19 LDTs that HHS halted in August 2020 based on a novel statutory interpretation that FDA lacked legal authority to require premarket review of any LDTs absent notice-and-comment rulemaking. Developers of COVID-19 LDTs that do not yet have FDA Emergency Use Authorization (“EUA”) need to be aware of these changes and consider what actions to take in response.

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COVID-19 Issues and Considerations for AMCs

Practices: Health Care

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Coronavirus Landing Site

This document summarizes the current key issues and considerations for AMCs arising from statutory, regulatory, and industry responses to COVID-19, and is intended to serve as a checklist for AMC legal offices, as they triage the unprecedented demands that they and their organizations more broadly face as a result of the COVID-19 crisis.

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