Seven types of surgical and examination gloves won’t require FDA oversight anymore, the HHS said Monday in a move to permanently cut regulatory requirements that were initially curtailed during the pandemic.
These gloves are considered class one medical devices, the lowest risk label for medical products the Food and Drug Administration oversees. They’ll now be permanently excluded from the FDA’s medical device regulatory scheme.
In addition, the Department of Health and Human Services is proposing that certain sterilizers, digital imaging software, face masks, and ventilators be excluded from FDA review. In total, 83 different types of class two medical devices ...
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