Revised Letter: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Source: U.S. Food and Drug Administration (FDA). Published: 5/7/2020. This eight-page letter, revised on May 7, 2020, updates the April 3, 2020, EUA for certain product classifications for imported disposable filtering facepiece respirators that are manufactured in China and not approved by the Centers for Disease Control and Prevention ’s National Institute of Occupational Safety and Health (NIOSH). It was revised for clarity and to address concerns about sub-standard products, which includes revising the third criterion for eligibility and adding a process for removal from Appendix A. (PDF)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - Category: International Medicine & Public Health Source Type: news