By Brian Craig, J.D.
The FDA sets forth a policy to expand the availability of face masks and respirators and invites manufacturers to offer solutions.
In an effort to address shortages amid the COVID-19 public health crisis, the FDA has issued a guidance easing the restrictions on face masks and respirators for use by the general public and health care professionals. The FDA will not object to the distribution and use of face masks that are intended for a medical purpose without full regulatory compliance provided the face mask does not create an undue risk. The FDA also welcomes discussions with manufacturers to produce new face masks and respirators while also soliciting companies to facilitate the reprocessing of used N95 respirators through an emergency use authorization (FDA Guidance, March 27, 2020).
Background. The FDA has adopted an emergency policy to help address urgent public health concerns by clarifying the regulatory landscape of face masks and respirators, helping to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (including N95 respirators) for use by health care professionals in healthcare settings. The FDA issued the policy, which takes effect immediately, without prior public input because of the emergency.
Policy. Face masks and respirators are regulated by the FDA when they meet the definition of a device under the federal Food, Drug and Cosmetic Act (FDC Act). Generally, face masks fall within this definition when they are intended for a medical purpose, including for use by health care professionals. Face masks that are not intended for a medical purpose are not medical devices.
Wherever possible, health care facilities should continue to use FDA-cleared face masks and N95 respirators or better. The FDA set forth an emergency policy for face masks intended for a medical purpose that are not intended to provide liquid barrier protection. In response to the COVID-19 pandemic, the FDA will not object to the distribution and use of face masks that are intended for a medical purpose without full regulatory compliance provided the face mask does not create an undue risk. The FDA also set forth a policy on the use of surgical masks intended to provide liquid barrier protection where the face mask does not create an undue risk in light of the public health emergency.
Reprocessing of respirators. To facilitate the safe reuse and conservation of personal protective equipment (PPE) for the duration of the public health emergency, the FDA is interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators (and other filtering facepiece respirators) through an emergency use authorization (EUA) for reprocessed devices.
New face masks and respirators. The FDA is also inviting discussions with manufacturers, including foreign and domestic manufacturers, to increase the supply of new face masks and respirators. The FDA invites discussions from current face mask and respirator manufacturers whose products are not currently marketed in the United States. Furthermore, the FDA welcomes the opportunity to work with manufacturers not previously engaged in medical device manufacturing with the interest and capability to manufacture face masks and respirators. This may include U.S. manufacturers in other manufacturing sectors. Although approval will by on a case-by-case determination, the FDA is easing restrictions provided certain conditions are met.
The FDA recommends that firms interested reprocessing respirators and manufacturing new face masks and respirators contact the FDA by sending an email to [email protected], while also providing certain information included in the guidance to facilitate discussions.
MainStory: TopStory FDCActNews MDeviceNews SafetyNews
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