November 7, 2023 - FDA Roundup: November 7, 2023

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 Communication warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC. On November 6, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile: 
  • 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes); 
  • Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).

  These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit.

• On Monday, the FDA announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns. ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers. Published by the American National Standards Institute, Inc, and the Association for the Advancement of Medical Instrumentation, it aligns with existing international safety risk management standards and quality systems expectations. It also provides direction to sponsors on how to consider and address cybersecurity risks in device design and development. We encourage the use of this new standard to enhance quality and support product performance. Recognized Consensus Standards: Medical Devices 
• On Friday, the FDA published the “Catching Up with Califf:” “Thoughts on Singapore, and FDA’s Ongoing Work to Improve Public Health,” by: Robert M. Califf, M.D., Commissioner of Food and Drugs. As part of the recent trip to India, Dr. Califf and the FDA team also stopped by Singapore for a few days. Dr. Califf reflects on the trip to Singapore, shares thoughts about the FDA’s global presence and strengthening ties with an FDA strategic partner, touches on opportunities and challenges in applying technological innovation around the world and adds some additional reflections about this part of the world.
• On Friday, the FDA issued an updated advisory for the investigation of elevated lead levels linked to certain apple cinnamon puree pouches. Exposure to lead can be particularly harmful to children. Consumers should not eat, sell, or serve recalled WanaBana, Schnucks, and Weis brand apple cinnamon pouches and should discard them. The FDA has received additional reports of illnesses and is working to evaluate those complaints. The FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. The FDA will update this advisory as information becomes available. 
• On Friday, the FDA cleared for marketing the Control-IQ Technology, a software-only device intended for use with compatible integrated continuous glucose monitors (iCGMs) and alternate controller-enabled insulin pumps (ACE pumps) for the management of type 1 diabetes in persons two (2) years of age and older. Control-IQ Technology—along with its compatible iCGMs and ACE pumps—can automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold (for example, based on carbohydrate intake, exercise, and sleep schedule). Control-IQ Technology is for prescription-use only. This is the latest example of the FDA’s ongoing commitment to help advance the development and expansion of products that can improve the management of type 1 diabetes, especially for pediatric patients. In addition to the clinical studies that the FDA reviewed to support this clearance, Tandem Diabetes Care, Inc., the manufacturer of Control-IQ Technology, will also conduct a post-market surveillance study with subjects ages 2-5 years old to collect additional information on device performance during real-world use.FDA reviewed to support this clearance, Tandem Diabetes Care, Inc., the manufacturer of Control-IQ Technology, will also conduct a post-market surveillance study with subjects ages 2-5 years old to collect additional information on device performance during real-world use.
   

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