Date Updated: January 17, 2017 Audience: Users of the PENTAX Medical (PENTAX) ED-3490TK Video Duodenoscope and reprocessing facilities including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties: Gastroenterology, Infection Control Device: PENTAX ED-3490TK Video Duodenoscope Summary of Problem and Scope:…
Emergency Use Authorization Amendment: Letter Granting EUA Amendment(s) for the Trioplex Real-time RT-PCR (CDC)
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication
Date Issued: January 13, 2017 Audience: Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) ED-530XT duodenoscope, as well as users of Fuji’s ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 duodenoscopes including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties:…
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Guidance for Investigational Device Exemption Sponsors, Sponsor
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Meeting Notice: March 17, 2017 Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory…
Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance
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Class I Medical Device Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial
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Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication
Date Issued: January 11, 2017 Audience: Patients who have an implantable infusion pump Caregivers of patients with an implantable infusion pump Health care providers who treat or manage the care of patients with implantable infusion pumps Health care providers and MR technologists involved in the magnetic resonance imaging of patients with implantable infusion pumps Specialties:…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150059, DEN160003, and DEN160020 added)
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Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication
Date Issued: January 9, 2017 Audience: Patients with a radio frequency (RF)-enabled St. Jude Medical implantable cardiac device and corresponding Merlin@home Transmitter Caregivers of patients with an RF-enabled St. Jude Medical implantable cardiac device and corresponding Merlin@home Transmitter Cardiologists, electrophysiologists, cardiothoracic surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems…