FDA Recap: July 18, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news from the agency.
On Monday, the FDA announced the findings from a pilot program evaluating private third-party food safety audit standards. The program aimed to assess the alignment of these standards with the requirements of the FDA Food Safety Modernization Act (FSMA). The FDA issued two regulations, known as the Preventive Controls for Human Food and the Produce Safety rules, to implement the FSMA. The findings of this pilot program will help inform future efforts to ensure food safety.
Also on Monday, the FDA published a Spotlight on CDER Science, highlighting a laboratory study conducted by the Center for Drug Evaluation and Research (CDER). The study examined the effects of mixing an oral antacid, pantoprazole sodium, with different foods. The researchers found that the food vehicle can impact the performance of the drug, which has implications for evaluating drug safety and efficacy. This study emphasizes the importance of considering the interaction between drugs and food.
The FDA also issued a safety communication on Monday, warning consumers against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. These devices have not undergone FDA review, and their safety and effectiveness have not been established for diagnosing, treating, or curing medical conditions. The FDA advises consumers to avoid using these devices and consult with healthcare professionals for appropriate medical devices.
On Friday, the FDA granted marketing authorization for the Ruthless Spine RJB device. This device is designed to measure the angle of surgical instruments relative to gravity during certain spinal surgeries that involve the placement of lumbosacral pedicle screws. The RJB device is intended for use under the guidance of an x-ray and is not meant to replace a surgeon’s clinical judgement.
Additionally, the FDA made updates to its Medical Device Shortages List webpage, removing several product codes related to specimen collection, laboratory reagents and testing supplies, transport media devices, saline vascular access flush products, and certain ventilation-related products. These updates reflect changes in the availability of these medical devices and supplies.
The FDA’s mission is to protect public health by ensuring the safety, effectiveness, and security of various products, including drugs, vaccines, medical devices, food, cosmetics, dietary supplements, and tobacco products. The agency plays a crucial role in regulating these products to safeguard public health.