Despite the current Covid-19 public health emergency in the United State which has the most infection cases in the world, many Americans were told that masks do not help unless one is sick. But the reality is that masks have been helpful in mitigating the spread of airborne diseases in many parts of the world. The U.S. CDC announced on Friday, April 3, 2020, an advisory for Americans to wear masks when in public and many companies are starting to provide masks to their employees. More importantly, in a medical setting, masks are critical to protect the medical health professionals as well as patients. However, many hospitals in hot spots such as New York City are running out of masks and there are some reports of health professionals reusing or washing masks or worse yet, not having masks at all.
There is now great demand for this product, the majority of which are produced in China. Companies such as 3M have stepped up their production, but the reality is that U.S. domestic production will not be enough.
Face masks and respirators in the U.S. are regulated by the U.S. Food & Drug Administration (FDA) when they meet the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic Act. Generally, face masks fall within this definition when they are intended for medical purposes. Face masks that are not intended for medical purposes are not medical devices. Each type of face mask intended for medical uses have specific FDA product codes such as ONT for N95 respirator with antimicrobial/antiviral agent or ORW for N95 respirator with antimicrobial/antiviral agent for use by the general public in public health emergencies. Surgical masks are also in a different product code category.
National Institute for Occupational Safety and Health (NIOSH) Approved N95 respirator is an N95 respirator approved by NIOSH that meets filtration efficiency level but may not be a FDA class II device. These are normally used in construction.
For face masks and FFRs that are for the general, non-medical public such as for use in construction are not FDA regulated and FDA device marketing authorization is not required. Given the current public health emergency, while the FDA recommends that health care providers follow CDC guidance on personal protective equipment (PPE), FDA does not intend to object to the distribution and use of face masks that are intended for medical purposes without compliance with certain regulatory requirements such as premarket notification, registration and listing, unique device identification requirements, etc. as long as the product labels accurately describe the product as a face mask as opposed to surgical masks or FFR; labeling that recommends or warns against use in surgical settings; and does not include antiviral or particulate filtration claims.
However, for surgical masks that are considered FDA class II devices, while premarket notification to the FDA may not be required during this public health emergency, they must still meet fluid resistance testing with standard ASTM F1862; meet flammability requirements; labeling as a surgical mask; list body contacting materials; and do not include any false claims on antimicrobial/antiviral or particulate filtration capabilities.
At the time of importation, non-FDA regulated devices (masks) do not require additional submission of information to the FDA on top of customs required information. However, for FDA regulated masks, certain procedures are available to expedite the FDA clearances. When importing such products, entry information should be submitted to the FDA; however during this public health emergency, reduced FDA information is required for review. At the time of entry, importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in the Automated Customs Environment (ACE). As most importers use a freight forwarder or a customs broker to handle the customs entry process, they should ensure that their freight forwarder or customs broker is well versed in the current FDA requirements. Currently, Customs and Border Protection (CBP) and the FDA are stopping imports of masks and other PPEs that do not meet regulatory requirements or may be mislabeled.
Other regulatory requirements related to such matters as country of origin marking, FDA registration for importers, Federal Trade Commission Act (false advertising), trademarks, etc. should also be considered. The FDA has also issued emergency guidance on the importation of ventilators, hospital gowns and other PPEs.