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Emergency Use Authorizations
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…
July 2016 PMA Approvals
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Meeting Notice: September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting Announcement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] National Mammography Quality Assurance 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 committee meeting of the National Mammography Quality Assurance Advisory Committee. The general function…
Class I Medical Device Recall: Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage
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Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall
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Consumer Information on: Closer Vascular Sealing System
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Medical X-Ray Imaging Devices Conformance with IEC Standards
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Consumer Information on: PD-L1 IHC 28-8 pharmDx
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Comfort Shield Barrier Cream Cloths by Sage Products: Recall
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