SILVER SPRING, Md. , Aug. 6, 2024 /PRNewswire/ -- 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 algorithm.