ABSTRACT

Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities [April 2, 2020]   [open pdf - 431KB]

From the Document: "The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain both globally and domestically. Perhaps most salient has been the impact of COVID-19 on the availability of personal protective equipment (PPE), such as gowns and masks, for health care personnel, and respiratory devices, including ventilators, for patients. In the United States, respiratory devices and PPE used in the health care setting meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FFDCA) and are regulated by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). This In Focus provides an overview of how these devices are regulated and summarizes the FDA response to mitigate reported PPE and ventilator shortages related to COVID-19."

Report Number:
CRS In Focus, IF11488
Author:
Publisher:
Date:
2020-04-02
Series:
Copyright:
Public Domain
Retrieved From:
Congressional Research Service: https://crsreports.congress.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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