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Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication
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Updated Information on Expanded Access for Medical Devices
Introduction When a patient has a serious or life-threatening condition that is not addressed by current approved treatments, options may exist to use an investigational medical device (i.e., one that has not been approved or cleared by FDA) to treat the patient. Normally, such investigational devices with significant risks may only be used on human…
Summary Information for: JUVÉDERM VOLBELLA® XC
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MDUFA Quarterly Performance Report
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Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication
[Posted 06/01/2016] AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing ISSUE: The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken…
Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stockert 3T Heater-Cooler System: FDA Safety Communication
June 1, 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 Medical Specialties Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons,…
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
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FDA Voice Blog: Celebrating a Year of the Expedited Access Pathway Program for Medical Devices
By: Erin Cutts, B.S., Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D The U.S. Food and Drug Administration (FDA) is committed to supporting patient access to high-quality, safe, and effective medical devices of public health importance — as quickly as possible. Erin Cutts, B.S., Policy Lead, Q-Submission Program (acting), Office of Device Evaluation in FDA’s…
Meeting Materials posted for June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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