FDA Roundup: June 20, 2023

FDA News Release

• For Immediate Release: June 20, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA released its report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-service Restaurants. According to the Centers for Disease Control and Prevention (CDC) more than half of foodborne illness outbreaks that occur each year are associated with food from restaurants. This report summarizes the agency’s findings from the 2017-2018 data collection, and is part of the FDA’s 10-year (2013-2022) study on trends in the occurrence of foodborne illness risk factors and food safety behaviors and practices in food service facilities. Risk factors are food preparation practices that can contribute to outbreaks of foodborne illness, such as inadequate cooking, poor personal hygiene, or using food from unsafe sources.
• On Friday, the FDA authorized marketing of the Invictus Medical, Neoasis, a prescription medical device intended to reduce noise levels inside the Giraffe Omnibed infant incubator in the neonatal intensive care unit (NICU). It also allows the infant to hear the caregiver’s voice through a speaker placed inside the incubator. A NICU is often considered a high noise environment and high noise levels may affect an infant’s well-being and development. The device uses a software algorithm to detect noise levels in the environment and to produce a noise cancelling effect through the speaker. The software, which includes important patient safety features, and noise cancellation performance were validated.