Deborah Shelton

Deborah Shelton

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FDA Issues EUA for Face Masks

This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment...more

4/23/2020  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Personal Protective Equipment , Public Health , Re-Opening Guidelines

FDA Issues Enforcement Policy for Ventilators and Other Respirators

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more

3/31/2020  /  Coronavirus/COVID-19 , Enforcement , Food and Drug Administration (FDA) , Health and Safety , Infectious Diseases , Medical Devices , Policies and Procedures , Public Health , Risk Management , Workplace Safety

FDA Issues Enforcement Policy for Gowns, Other Apparel, and Gloves

As part of its ongoing effort to address the critical shortage of Personal Protective Equipment (PPE) needed to address the COVID-19 pandemic, FDA has issued an Enforcement Policy to help expand the availability of surgical...more

3/31/2020  /  Coronavirus/COVID-19 , Crisis Management , Health and Safety , Personal Protective Equipment , Policies and Procedures , Public Health , Risk Management , Workplace Safety

FDA Issues Enforcement Policy for Ventilators and Other Respirators

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more

3/31/2020  /  Best Practices , Coronavirus/COVID-19 , Health and Safety , Infectious Diseases , Policies and Procedures , Public Health , Regulatory Standards , Risk Management , Workplace Safety
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