There has been a lot of coverage about the shortage of N95 masks. Below is a quick breakdown of the regulatory oversight of N95 masks and how the FDA and CDC are working together.
The majority of N95 respirators are manufactured for use in the construction or industrial industry. These masks are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC)
Some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.
This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA), acting through its Center for Devices and Radiological Health (CDRH), and the Centers for Disease Control and Prevention (CDC), acting through its National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL) (herein referred to as “the Agencies”), provides a framework for coordination and collaboration between the Agencies relating to their regulation of Surgical N95 Respirators and N95 Filtering Facepiece Respirators (FFRs)1 used in healthcare settings (herein collectively referred to as “N95s”).
A coordinated process will help to ensure that the various regulatory activities of each agency related to N95s are streamlined and harmonized when possible. The intent of this MOU is to help reduce conflicting and duplicative premarket processes for these devices so that stakeholders can easily and seamlessly discern what steps must be taken to satisfy the applicable regulatory requirements.
Specifically, this MOU (1) describes the mechanisms by which specific information pertaining to N95s may be exchanged between the two Agencies and (2) provides a framework for efficient and coordinated regulatory oversight of N95s intended for use in healthcare settings.