FDA Roundup: August 6, 2024

FDA News Release

• For Immediate Release: August 06, 2024

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

• On Monday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell, and consumers not to eat certain oysters from Lewis Bay, Massachusetts, due to potential contamination with Campylobacter jejuni.
• On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) released a Discussion Paper: Health Equity For Medical Devices to obtain feedback about ways to help ensure that all patients have timely access to safe, effective, and high-quality medical devices and safe radiation-emitting products. This paper requests feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device. Consistent with CDRH’s 2022 to 2025 Strategic Priority to advance health equity, this paper is intended to spur discussions about reducing barriers to achieving health equity and strategies that may help improve outcomes across diverse populations. Please submit comments under docket number FDA-2024-N-3616 at www.regulations.gov by October 4, 2024.
• On Monday, the FDA’s Digital Health Center of Excellence (DHCoE) published its summer edition newsletter that shares the latest digital health advancements to protect and promote public health. As AI continues to advance with more sophisticated algorithms and more data available than ever before, it's important to consider ways to align on methodologies, best practices, and quality assurance standards to help all people living in the U.S. truly benefit from AI's tremendous capability in health care settings. In this edition, DHCoE explores these concepts and potential approaches for addressing these questions. 
• The FDA’s Office of Regulatory Affairs (ORA) has partnered with the National Association of State Departments of Agriculture (NASDA) and the North Carolina State University (NC State) to create a new course to introduce degree and non-degree seeking students to the possibilities of a career in public health.  This dynamic new course, Introduction to Public Health Food Inspections, is the first of its kind anywhere in the country and offers students a comprehensive understanding of the federal regulatory food inspections and enforcement system.  To learn more about this dynamic new course, please visit www.nasda.org/inspectioncourse.  Completion of the course offers students college credit to build their resumes as well as a potential pathway for equivalency testing for specific topics. Students with these credentials and training will be sought after by the Agency and should strongly consider applying for vacant positions advertised on USA Jobs, and for positions with our state and local public health partners. In the future, the FDA and NASDA hope this course can be replicated at other higher education institutions across the country.