PPB August 2020

THINK • for use in the presence of a high intensity heat source or flammable gas • for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, or • to include particulate filtration claims. Find more information in the Face Mask Emergency Use Authorization (Letter), issued by the U.S. Food and Drug Administration on April 24, 2020, at www.fda.gov/ media/136449 download. Instructions on the cleaning and care, if applicable, must be provided to end users in hard copy or via an alternative format with instructions on how to access. Similar to the manufacturing requirements for medical masks, the FDA requires manufacturers to maintain production records, traceability and a recall process. The EUA provides guidelines for manufacturers and distributors, including manufacturers and distributors of promotional products, related to printed inserts and packaging. No claims should be made nor statements that suggest the product “is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic.” Companies unfamiliar with FDA regulations for devices should consider the regulatory requirements and the scope of the EUA and should then determine if compliance, under these specified conditions, is achievable. The mask images in this article are for illustration purposes only. D.E. Fenton was most recently executive director at Quality Certification Alliance. After 12 years, the organization concluded its mission and wrapped up operations as of August 1. PPAI Product Responsibility Summit Goes Virtual For 2020 PPAI’s 2020 Product Responsibility Summit will be held in a virtual format on September 14-18 offering industry-specific topics and sessions focused on vetting supply chains, introducing new product categories while remaining compliant and everything related to personal protective equipment. The programs will be facilitated by subject matter experts and industry thought and business leaders. Attendees receive a free digital resource manual, access to optional 101 education sessions (prior to the event), MAS-level education credits and PSA designation or designation renewal. Register at ppai.org/events/virtual-product-responsibility-summit. Companies unfamiliarwith FDA regulations for devices should consider the regulatory requirements and the scope of the EUAand should thendetermine if compliance, under these specified conditions, is achievable. Anzhela Shvab / Shutterstock.com 82 | AUGUST 2020 |