FDA Revokes EUA For Curative Test, Slew Of Other COVID-19 Products

In an ongoing trend, the US agency announced it revoked a number of emergency use authorizations at the behest of manufacturers.

A box full of N95 masks
The FDA has revoked more face mask authorizations • Source: Alamy

The US Food and Drug Administration says it has revoked emergency use authorization for a COVID-19 test made by Curative Inc., and 15 other products such as decontamination systems and face masks. The latest announcement adds to the growing list of EUA products no longer authorized to be on the market.

The FDA said in the 31 August Federal Register that it pulled EUAs for the Curative-Korva SARS-Cov-2 Assay and number of other products.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By 

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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

 
• By 

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.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.