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February 1, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 31, 2024. To view listings for other dates, see CDRH New - News and Updates.

• Materials for February 2, 2024 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting
• Mammography Quality Standards Act and Program (Updated)
• Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions (Updated)
• Quality and Compliance (Medical Devices) (Updated)
• Overview of Device Regulation (Updated)
• Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) (Updated)
• Class I Recall: Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist
• Consumer Information: Aurora EV-ICD System - P220012 (Medtronic, Inc.)
• Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines (Updated)
• CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
• Federal Register: Medical Devices; Quality System Regulation Amendments