Stakeholders Look To Becerra To Restart FDA Regulation of LDTs

By Kelly Lienhard / March 26, 2021 at 5:35 PM
Proponents of FDA device regulation hope to see new HHS head Xavier Becerra reinstate FDA’s jurisdiction over laboratory-developed tests after the Trump HHS told the agency it no longer had the authority to regulate the tests. The FDA regulatory experts told Inside Health Policy the COVID-19 pandemic has shown a need for HHS to reverse its position on LDTs to ensure the public can rely on diagnostic tests being safe and accurate. FDA’s authority to regulate LDTs became...

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