FDA updates respirator EUA workflow
Manufacturers and distributors of respirators for health care workers during the coronavirus pandemic received detailed updates, including a new flowchart, from the US Food and Drug Administration (FDA).The flowchart clarifies procedures for manufacture and distribution of a variety of respirators under the emergency use authorizations (EUAs) for respirators that FDA has issued during the COVID-19 pandemic. (RELATED: Pandemic prompts mask, ventilator EUAs from FDA, Regulatory Focus 07 August 2020)
Reusable respirators such as elastomeric or powered air purifying respirators (PAPRs) require the approval of the National Institute of Safety and Health (NIOSH) prior to marketing or distribution in the US. NIOSH-approved air purifying respirators are covered by a separate EUA.
Respirators designed to be disposable filtering facepiece respirators, such as N95 respirators, that have NIOSH approval are governed by a separate EUA path. “All previously FDA approved or cleared respirators are NIOSH-approved,” FDA clarified in its announcement of the updated flowchart.
For non-NIOSH approved respirators, the applicable EUA depends on the country of manufacture. Respirators manufactured in the US require NIOSH approval or FDA clearance; an application for EUA can be made upon NIOSH approval.
Disposable filtering facepiece respirators made in China must either be FDA cleared or authorized under a dedicated EUA entitled Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China.
A parallel pathway exists for respirators manufactured outside of the US and outside of China; manufacturers of these respirators can either apply for FDA clearance or for an EUA for non-NIOSH-approved disposable filtering facepiece respirators.
Further information about importing personal protective equipment and medical devices during the COVID-19 pandemic is available on FDA’s website.