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FDA updates draft guidance on safety of US blood supply
Editor's Note The Food & Drug Administration on December 4 updated a draft guidance that promotes the development and adoption of innovations to ensure continued safety of the US blood supply. The draft guidance entitled, “Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety…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…
FDA: Fresenius Kabi recalls sodium chloride injection
Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…
FDA launches app for EHR data collection
Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…
FDA guidance updates UDI compliance policy
Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…
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