CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on February 4, 2019. Previous CDRH Newitems can be found on the CDRH New webpage. Class I Recall: Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers Mammography Facility Adverse Event and Action Report - February 01, 2019: South Shore Radiology A Division of Prohealthcare Howard Beach The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff (PDF - 484KB) Webinar - The Least Burdensome Provisions: Concept and Principles Final Guidance - March 14, 2019 CDRH's Experiential Learning Program Federal Register: The Least Burdensome Provisions: Concept and Principles