FDA’s Temporary Enforcement Policy for Face Masks

by | Apr 6, 2020 | Coronavirus, FDA, Medical Devices, Pharma, Quality Systems, Requirements

Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA released a guidance document that relaxes the regulations surrounding the manufacture of PPEs. The guidance is intended to stay in effect only until the end of the public health emergency.

Face masks and respirators that are intended for medical purposes are regulated under the FDA and require premarket notification submissions; examples include surgical masks, N95 respirator, pediatric facemask, etc. However, FDA states that face masks that are currently being used in the outbreak by individuals but are not intended for medical purposes such as masks for construction and industrial applications are not subject to FDA requirements.1

During the COVID-19 outbreak, FDA does not intend to object to the distribution and use of face masks (not including respirators) that are intended for a medical purpose without following the regulatory requirements of submitting a 510(k), establishment registration and product listing, quality system regulation, reporting, corrections, removals, and UDI requirements as long as the products do not create undue risks to the public health by means of appropriate labeling and avoiding any false claims.1

Surgical masks that provide a physical barrier to fluids and particulate materials are considered class II products under the FDA and are tested for flammability and biocompatibility. In light of the pandemic, FDA does not intend to object its distribution and use without prior submission of a 510(k) and appropriate establishment registration and listing, as long as the masks do not create an undue risk to the public health. FDA believes such undue risk can be avoided when the product meets ASTM testing standards, meets flammability requirements for class I and class II products and complies with appropriate labeling requirements.1

Also, during this time of PPE supply shortages, FDA is interested in speaking with manufacturers who can reprocess single-use masks such as N95 and work with them to get an Emergency Use Authorization for their reprocessed single-use products.1

FDA still encourages the use of FDA-cleared face masks and NIOSH-approved and/or FDA-cleared N95 respirators or better wherever possible.

If you are a manufacturer with the ability to manufacture PPEs, call us at 248-987-4497 or email us at info@emmainternational.com. We can help you navigate the FDA to safely get your products to help with the supplies shortages during the COVID pandemic.

1 FDA (March 2020) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency retrieved on 04/01/2020 from https://www.fda.gov/media/136449/download

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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