The U.S. Food and Drug Administration (FDA) ramped up the number of emergency use authorizations it granted to medical devices to address the COVID-19 pandemic, which some researchers have since scrutinized.
FDA granted emergency use authorization to many medical devices during the pandemic without any documented supporting data, according to a study published in JAMA Internal Medicine.
The study found 32 of the 54 medical device EUAs lacked supporting evidence, with most of the other authorizations backed by laboratory data. A similar picture emerges in the analysis of in vitro diagnostics, which were authorized without testing “against criterion standard.”
Read the full article at MedTechDive.