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COVID-19: FDA Clarifies New Guidance, NCI Role

 
• By Elizabeth Orr

An official from the US agency focused on new coronavirus diagnostic guidance, testing for asymptomatic individuals, and a National Cancer Institute validation project in a recent teleconference.

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The US Food and Drug Administration’s recent decision to more closely regulate COVID-19 antibody tests has raised some concerns for industry, a recent virtual town hall hosted by the agency indicates.

The FDA updated its guidance on both diagnostic and antibody tests, also known as serological tests, on 4 May. Under the new guidance, antibody test manufacturers must submit validation data...

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Zika Virus Test Among 4 New FDA Device Classifications

 
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The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

More from Device Area

Medtronic To Spin Out Diabetes Unit As New Products Solidify Turn-Around Story

 
• By Shubham Singh

Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
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TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

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