October 13, 2016 Audiences: Health care providers who use 3T Heater-Cooler System Primary care providers who are responsible for the ongoing care of patients who have undergone cardiothoracic surgery Patients who have undergone cardiothoracic surgery Hospital staff who are responsible for operating and maintaining 3T Heater-Cooler System Health care facilities that perform procedures using the…
Emergency Use Authorization Amendment: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)
On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.’s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria…
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication
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Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication
Date Issued: October 11, 2016 Audience: Patients with a St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device Caregivers of patients with a St. Jude Medical ICD and CRT-D device Cardiologists, electrophysiologists, cardiac surgeons, primary care physicians treating patients with heart failure or heart rhythm problems Medical Specialties: Cardiac Electrophysiology,…
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
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Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
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Transcripts posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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Class I Medical Device Recall: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination
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Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled “Medical Device User Fee Amendments.” The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2018 through 2022. MDUFA authorizes FDA to collect fees and use them for…
Transcript posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting
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