CDRH New Update

The following new items were added to the CDRH web pages on October 19, 2018. Previous CDRH New items can be found on the CDRH New webpage.

• Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems: FDA Safety Communication
• Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050