Coronavirus EUA Submission

Coronavirus EUA Submission– Importing N95 Masks and Hand Sanitizers

As the novel COVID-19 Coronavirus continues to spread our office has been flooded with Coronavirus EUA submission requests. Many questions are about how to import medical devices and drugs, in particular, and 95 masks and hand sanitizers. It is important to remember that the FDA continues to regulate these products even during the coronavirus outbreak. It is important to remember that the FDA continues to regulate these products (and all of regulated industry) even during the Coronavirus outbreak. In other words, the pandemic does not really authorize or allow the sale of any medical device or drug product without completing the proper procedures without the proper labeling. The basics of regulatory compliance still apply (See the recent Coronavirus Warning Letters).

The Coronavirus has surged the demand for face masks. The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use (See the infographic below). A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as surgical masks. An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s. Since the Coronavirus outbreak began, the FDA and CDC both are recommending the use of face masks if you are sick.

N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:

  • The respirator is intended to prevent specific diseases or infections, or
  • The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
  • The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

The Coronavirus has created a shortage of hand sanitizers. Hand sanitizers are regulated as OTC monograph drugs and there are three separate monographs, one for consumers, one for healthcare, and one for first aid. You will need to select a monograph and label accordingly. No, a sanitizer or disinfectant for services like countertops is not regulated by the FDA but instead by the EPA.

As the Coronavirus pandemic continues it is important to maintain regulatory compliance and make use of certain FDA processes, as needed, such as emergency use authorizations.

Coronavirus FDA EUA Policy Masks Face Shields
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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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