FDA warns of link between breast implants and anaplastic large cell lymphoma
Editor's Note The Food and Drug Administration (FDA) on February 6 posted a letter that was sent to healthcare providers to increase their awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). As of September 30, 2018, the…
FDA: Sun Pharmaceutical recalls four lots of Vecuronium Bromide
Editor's Note The Food & Drug Administration (FDA) on January 8 announced the recall by Sun Pharmaceutical Industries, Inc (Cranbury, New Jersey) of three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder) (Lots: JKS0443A, JKS0444A, JKS0477A), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder)…
FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software
Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…
FDA Pre-Cert Pilot Program to promote more efficient review of digital health innovations
Editor's Note The Food and Drug Administration (FDA) on January 7 issued a statement from Commissioner Scott Gottlieb, MD, on the agency’s new actions under the Digital Health Pre-Certification (Pre-Cert) Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations. Because digital…
FDA: Fluoroquinolone antibiotics can increase risk of aortic ruptures
Editor's Note The Food and Drug Administration (FDA) on December 20 announced that fluoroquinolone antibiotics can increase the occurrence of ruptures or tears in the aorta. The FDA recommends that healthcare professionals: Avoid prescribing fluoroquinolone antibiotics to patients who have or are at risk for having an aortic aneurysm, and…
FDA issues statement on updated rates of duodenoscope contamination
Editor's Note The Food and Drug Administration (FDA) on December 10 issued a statement on an updated safety communication about rates of duodenoscope contamination obtained from preliminary postmarket data. Interim results from sampling studies from device manufacturers−Olympus, Fujifilm, and Pentax− indicate higher-than-expected contamination rates after reprocessing. Up to 3% of…
FDA updates draft guidance on safety of US blood supply
Editor's Note The Food & Drug Administration on December 4 updated a draft guidance that promotes the development and adoption of innovations to ensure continued safety of the US blood supply. The draft guidance entitled, “Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety…
FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration
Editor's Note The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious. The recall was initiated because of a software defect that could potentially result…
FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators
Editor's Note The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious. The recall was initiated because of the…
FDA plans big changes to 510(k) pathway
Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…
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