Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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Editor's Note The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices. The guidance builds on the FDA’s existing efforts to ensure the safety and effectiveness of medical devices at…

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Editor's Note The Food and Drug Administration (FDA)  on January 15 cleared the Olympus TJF-Q180V duodenoscope with design and label modifications intended to reduce the risk of bacterial infections. The new design of the elevator channel sealing mechanism creates a tighter seal and reduces the potential for leakage of fluids…

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Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…

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Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall of Stryker Fuhrman’s Pleural and Pneumopericardial Drainage Sets as Class I, the most serious. Stryker (Tempe, Arizona) received two reports that the catheter included in the Drainage Set broke off in the patient’s pleural cavity during…

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Editor's Note The Food and Drug Administration (FDA) announced January 6 that Hospira, Inc (Lake Forest, Illinois) recalled one lot of Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry November 1, 2016). The recall was initiated because of…

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Editor's Note The Food and Drug Administration (FDA) on January 4 issued two final orders to strengthen the requirements for surgical mesh to repair pelvic organ prolapse tranvaginally. One order reclassifies surgical mesh from class II (moderate risk) to a class III (high-risk) device. The second order requires manufacturers to…

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Editor's Note The Food and Drug Administration on January 5 announced that Baxter International, Inc (Deerfield, Illinois) is recalling two lots of IV solutions because of the presence of particulate matter. The particulate matter was determined to be an insect and was identified as a result of a customer complaint.…

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Editor's Note The Food and Drug Administration (FDA), on December 31, 2015, released draft guidance on “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The draft proposes a policy for how the FDA will notify the public about “emerging signals” (ie, new information) of possible device risks before…

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Editor's Note The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to…

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