FDA Safety Concerns on China Facepiece Respirators

FDA says it is concerned that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection to health care personnel exposed to Covid-19 based on filtration performance testing conducted by CDC’s National Institute for Occupational Safety and Health (NIOSH). Because of the concerns, the agency revised and reissued a 4/3 emergency use authorization (EUA) for such respirators (Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China) to revise eligibility criteria, according to an FDA notice. A number of the respirators failed to demonstrate a minimum particulate filtration efficiency of 95% in testing conducted at NIOSH and have been removed from the EUA's appendix. The agency notes that the devices not meeting the performance standard can be re-labeled as face masks and authorized if certain criteria are met under the Face Mask umbrella EUA.