Comment from Johns Hopkins Center for Health Security

The Johns Hopkins Center for Health Security supports the steps proposed by FDA to simplify the US regulatory approval process for filtering facepiece disposable respirators and elastomeric reusable half-mask respirators that are worn by essential workers, including healthcare workers and first responders, to protect against transmission of respiratory pathogens. We endorse efforts that will achieve the stated objective, '...to facilitate more efficient and effective use of resources, consistent with the least burdensome policies for devices.' Under the current framework, NIOSH takes approximately 60 to 100 days to issue an approval. In the past, despite a minimal regulatory function played by FDA with respirator approvals (primarily limited to biocompatibility, flammability, and fluid resistance with "surgical N95s"), the involvement of FDA adds to delays in respirator approval and often confuses procurement officials, employers, the general workforce, and other consumers who utilize them. The involvement of FDA in respiratory protection regulation does not serve the US consumers in a beneficial fashion. The US workforce and the general public would be best served by having one regulatory agency (NIOSH) be responsible for regulating the approval of respirators.