[20200922]IF11488_个人防护设备（PPE）和新冠肺炎-19：FDA法规和相关活动.pdf

https:/crsreports.congress.gov Updated September 22, 2020Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related ActivitiesThe Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain globally and domestically. The impact of COVID-19 on the availability of personal protective equipment (PPE), such as gowns, gloves, respirators, and surgical masks, for health care personnel continues to be a concern. PPE is generally worn by health care personnel to protect the wearer from infection or illness from blood, body fluids, or respiratory secretions. In the United States, PPE intended for use in the cure, mitigation, treatment, or prevention of disease meet the definition of a medical device (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). PPE that do not meet the FFDCA definition of device (i.e., not intended for medical use) are not regulated by FDA. This In Focus provides an overview of how FDA regulates PPE and summarizes the agencys response to mitigate reported PPE shortages related to COVID-