FDA Roundup: July 18, 2023

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Jul 18, 2023, 16:16 ET

SILVER SPRING, Md., July 18, 2023 /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 announced the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.
On Monday, the FDA published a Spotlight on CDER Science that describes a laboratory study focused on mixing an oral antacid with different foods. In this study, CDER researchers explored how pantoprazole sodium may perform differently when mixed (as granules) into different food vehicles. These researchers confirmed that a laboratory assessment can detect the effect of the food vehicle on the drug performance, which has implications for evaluating drug safety and efficacy.
On Monday, the FDA published a safety communication to warn consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions.
On Friday, the FDA granted marketing authorization for the Ruthless Spine RJB device, an intraoperative surgical angle measurement guide. This first-of-a-kind device is intended to measure the angle of the surgical instrument relative to gravity while placing lumbosacral pedicle screws during certain spinal surgeries. It is indicated for use during the implantation of lumbosacral pedicle screws, which immobilize the spine as fusion occurs, and is only to be used in surgeries under the guidance of an x-ray. The RJB device is not intended to replace a surgeon's clinical judgement.
On Friday, the FDA updated the Medical Device Shortages List web page to remove the following product codes:

Specimen Collection – Testing Supplies and Equipment (product codes: JKA, GIM, and KXG)
Laboratory Reagents and Testing Supplies – Testing Supplies & Equipment (product codes: QOF, JRC, LXG, PPM, NSU, OOI, and JJH)
Transport Media Device – Testing Supplies & Equipment (product codes: LIO, QBD, and JSM)
Saline, Vascular Access Flush – General ICU/ Hospital Products (product code: NGT)
Certain Ventilation-Related Products – (product codes: BZD, MNS, and MNT)

For information about how the FDA determines it is appropriate to remove product codes from the device shortage list, please visit our web page Supply and Shortages of Medical Devices: Frequently Asked Questions.

Additional Resources:

FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration