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April 09, 2020

Health Law Daily

FDA Warns Developers Of Serological Tests For COVID-19 That They May Face Enforcement For Falsely Claiming To Have FDA Approval

  • April 09, 2020

Bloomberg Law (4/8, Lee, Subscription Publication) reports the FDA has warned that over 70 developers of COVID-19 serological tests may face enforcement including possible product seizures for making false claims. Although the FDA has only “green lit only one company, Cellex Inc., through its emergency regulatory channel to use the tests in clinical labs,” some other “companies are also claiming their tests have been approved or authorized by the FDA when they haven’t, the agency said Tuesday.”