FDA issues draft guidance on UDIs
Editor's Note The Food and Drug Administration (FDA) on February 3 released a draft guidance document, “Enforcement policy on national health related item code and national drug code numbers assigned to devices.” The draft describes the FDA’s intent not to enforce before September 24, 2021, the prohibition against National Health…
FDA posts updated information on duodenoscope reprocessors
Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…
FDA: Class I recall of Optisure Dual Coil Defibrillation Leads
Editor's Note The Food and Drug Administration (FDA) on January 27 classified the recall of St Jude Medical’s (St Paul, Minnesota) Optisure Dual Coil Defibrillation Leads as Class I, the most serious. The recall was initiated because of a manufacturing error that may have damaged the insulation layer of one…
FDA: Baxter recalls four lots of IV solutions
Editor's Note The Food and Drug Administration (FDA) on January 27 announced that Baxter (Deerfield, Illinois) is recalling four lots of IV solutions because of the potential for leaking containers and particulate matter. The recall affects the following: 0.9% Sodium Chloride Injection, USP, 100 mL in Mini-Bag Plus Container (lot…
FDA: Draft guidance on designing interoperable devices
Editor's Note The Food and Drug Administration (FDA) on January 26 published draft guidance for “Design considerations and premarket submission recommendations for interoperable medical devices” to assist medical device manufacturers in designing products that are interoperable and can securely share data. The draft includes factors to consider when developing the…
FDA: Abbott recalls all sterile compounded products
Editor's Note Abbott’s Compounding Pharmacy (Berkeley, California) is recalling all lots of sterile compounded products because of concerns of lack of sterility assurance. Products include injectable medications, sterile solutions, eye drops, and eye ointments. The recall was issued after a series of onsite inspections by the Food and Drug Administration…
FDA issues final guidance for devices labeled as sterile
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…
FDA: Draft cybersecurity recommendations for device manufacturers
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…
Olympus recalls, redesigns Olympus TJF-Q180V duodenoscope
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…
FDA: Class I recall of Brainlab’s Cranial Image-Guided Surgery System
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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