Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance
As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers
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In a pair of guidance documents the US agency explains clearance options and its enforcement policy for sponsors of devices used to reduce contaminants in COVID-19 masks and respirators.
When asked about an inspector general report that found hospitals are struggling with tests and resources, and are looking to the federal government to help facilitate more efficient distribution of medical devices to fight the COVID-19 crisis, President Trump attacked the report as a political hit from an Obama holdover.
The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.