Webinar - Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance
April 6, 2020
- April 6, 2020
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On April 6, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19.
The FDA issued two immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19:
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) (April 2, 2020)
- Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency (March 30, 2020)
The FDA believes the policy set forth in these guidances may help address urgent public health concerns by helping to expand the availability of:
- General-use face masks for the general public;
- Particulate-filtering facepiece respirators (including N95 respirators); and
- Surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon's and patient-examination gloves during this public health emergency.