US FDA Issues New Enforcement Policy for Face Masks and Respirators

US FDA updates guidance on face masks and respirators with May 2020 publishing of “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)”.
( | Press Release | 2020-06-22 16:39:06 )
The US Food and Drug Administration (FDA) has again revised its guidance relating to face masks and N-95 respirators.

The latest guidance, issued in “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)”, discontinues policies previously published in March 2020 and April 2020.

Stakeholders should be aware the revised enforcement policy includes updates that will affect the selection of alternatives when FDA-cleared and NIOSH-approved N95 respirators are not available. NIOSH is the National Institute for Occupational Safety and Health.

Under April’s guidance, the FDA had allowed flexibility regarding the distribution and use of respirators identified in the Centers for Disease Control and Prevention (CDC) recommendations without compliance to certain regulatory requirements, including submission of a 510(k) under certain circumstances. The FDA also issued emergency use authorizations (EUAs) for certain respirators that it determined met the criteria for issue under Section 564 of the Act. Since the issue of the April guidance, however, the FDA has become aware that certain respirators where not performing adequately, and they therefore needed greater oversight.

The current guidance by the FDA is that FDA-cleared or NIOSH-approved N95 respirators should be used whenever possible. If they are not available, then FDA-authorized respirators should be used before other alternatives. It does not recommend using a respirator that is not FDA-cleared, NIOSH-approved, or authorized by them for emergency use.

The enforcement policy covers respirators, face masks, face shields “intended for a medical purpose”, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. It does not relate to items marketed to the public for general, non-medical purposes, such as use in construction and other industrial applications.

To learn more about the FDA’s enforcement polices relating to face masks and respirators during the COVID-19 pandemic, read our original SafeGuard 075/20.

SGS Medical PPE Services
SGS offers a full range of services to help manufacturers and suppliers of medical PPE deliver high quality, safe, and compliant products to markets around the world. Learn more about SGS Medical PPE Services. []

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full US FDA Issues Revised Face Mask and Respiratory Enforcement Policy SafeGuardS. []

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For further information contact:

Matthew Mcgarrity
Senior Technical Manager
Tel: +1 (973) 461 1505
LinkedIn: sgs-consumer-goods-&-retail

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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