PPB August 2020

• For non-medical masks: Clearly indicate product is not intended to be used in a health-care setting in the commercial documents and on the cartons. • Avoid efficacy claims for disease prevention. • Avoid antimicrobial / antiviral agents claims. • Maintain an effective recall process which could be activated to withdraw product from the market that may pose a risk to the end user. • Avoid marketing materials that may represent or suggest that the mask is safe or effective for the prevention of COVID-19. • Keep in mind the EUA will be effective only until the declaration that circumstances exist justifying the authorization of the emergency use of personal respiratory protective devices during the COVID-19 outbreak is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. For Face Masks Intended For General Use Manufactured Under EUAs The FDA-published EUAs fromMarch and April 2020 clearly distinguish general use “face masks” from non-surgical and surgical masks. General use products may not imply “antimicrobial or antiviral protection” or use marketing claims such as “for use such as infection prevention or reduction” or “for particulate filtration.” The FDA defines general-use face masks, whether they include or do not include a face shield, as covering the user’s nose and mouth. These face masks may or may not meet fluid barrier or filtration efficiency levels. General- use face masks also include cloth face coverings. Lastly, general-use face masks may be used for single or multiple uses and, if for multiple uses, they may be laundered or cleaned. Under the current EUAs, the FDA has authorized manufacturers and distributors to “make face masks available with labeling that include(d) a description of the product as a face mask, including a list of the body-contacting materials (which does not include any drugs or biologics).” The EUA also advises authorized manufacturers and distributors of these products against labeling the product: • as a surgical mask, to provide liquid barrier protection • or use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected • for use in a clinical setting where the infection risk level through inhalation exposure is high | AUGUST 2020 | 81 THINK