FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block
After criticism it was being too lax in overseeing COVID-19 antibody tests coming to market, the US agency issued an updated guidance earlier this month tightening regulations. As a result, it has now pulled more than two dozen tests that don’t meet its standards – and more are expected to follow.
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The agency is cautioning that current tests may give false negative results for patients with genetic mutations of SARS-CoV-2, making it harder to control the spread of the pandemic.
If not used properly the test can mislead some patients that they do not have the coronavirus. The US FDA says health care providers should consider using another test if patients get a negative result.
Medical device manufacturers are operating in what may be the industry’s most challenging business and regulatory environment in recent history, attorneys Bill McConagha and Pamela Amaechi argue in this guest article.