Devices
FDA says it is still evaluating information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. In 2021, the agency issued a notice saying that a real-world data analysis “indicates that procedural outcomes such as major
Drugs
Several Skadden attorneys say an increased focus on cybersecurity could pose False Claims Act (FCA) exposure risk for life sciences companies. Writing in a lengthy online newsletter, the attorneys review FDA’s promotional enforcement update, Warning Letters arising out of inspection activities, and a loss on statutory interpretation. The report
Devices
FDA says it is investigating an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, and is evaluating the need for regulatory action. The agency says it has received reports of T-cell malignancies, including CAR-positive lymphoma, in
Devices
FDA has issued a warning on Philips’ DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat. The agency says patients and healthcare providers should carefully monitor the devices for signs of overheating based on medical device reports (MDRs) it has received recently about thermal issues such
Devices
FDA has withdrawn its membership in the 32-member medical device Global Harmonization Working Party (GHWP), which is chaired by China, after failing to persuade the organization to align with other international harmonization efforts, such as the International Medical Device Regulators Forum (IMDRF). “Moving forward, FDA will spend the next
Devices
Unomedical is recalling certain VariSoft Infusion Sets due to the risk that the device’s connector may detach from the set which would disrupt insulin delivery. “If this occurs, insulin may continue to flow through the tubing that is now disconnected from the patient and the insulin pump would not
Devices
FDA has cleared a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use. The company says the watch was developed to be lifestyle-friendly to provide users with “untethered continuous pulse oximetry
Devices
FDA has published a draft guidance, Translation of GLP Study Reports: Questions and Answers, with information for sponsors and non-clinical laboratories about the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations. The document says GLP studies include nonclinical toxicology studies, safety
Devices
SoClean has recalled its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and accessories. The recall comprises a new User Manual with additional instructions for use and a hose and mask adapter that is intended to help reduce potential health risks of
Drugs
Writing in National Law Review, three Epstein Becker Green attorneys say medical product manufacturers should study an FDA 2023 draft guidance on sharing scientific information with healthcare providers on unapproved uses of medical products “to mitigate potential risk in navigating the often murky regulatory waters of engaging in off-label
FDA Policy/General
FDA commissioner Robert Califf says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video interview, Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.
Devices
FDA has approved a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension. The device works by delivering radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. The therapy is administered by catheter in the artery leading to the
Devices
FDA is warning healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates their compatibility with the devices. Recently, Cardinal Health recalled the syringes because their dimensions differ from the previously branded syringes and they may be
Devices
Asensus Surgical has recalled (Class 1) its Senhance Surgical System due to malfunctions that cause unintended movement of the robotically assisted surgical device. “This issue presented itself as an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed
Devices
Braun Medical has recalled (Class 1) its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms. “On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications, such as high-risk medications like vasopressors,” a recall notice says.
Devices
FDA has issued a final guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act, to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help
Devices
FDA has published a guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to assist the medical device industry in assessing the credibility of computational modeling used to support medical device PMA, HDE, and IDE applications, 510(k)s, and de novo classification requests, or qualification
Devices
A Mitre Corp. report, “Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks,” prepared under a contract with FDA, makes recommendations for protecting legacy medical devices that “cannot be reasonably protected against current cybersecurity threats.” The report says that because of the long lifetimes of medical devices and the lack
Drugs
FDA has launched a Web page devoted to its efforts to research and promote alternative methods for product testing. The page says alternative methods “have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing, and/or refining
Devices
Baxter Healthcare has recalled (Class 1) its Novum IQ Syringe Infusion Pump because the device may indicate an infusion is complete when it is not. The problem has been identified as a software error that may “miscalculate volume after the pump detects a blockage (occlusion),” according to a recall notice.
Devices
Israel’s IceCure Medical says it is appealing FDA’s denial of the company’s de novo classification request for its ProSense system to treat patients with early-stage, low-risk breast cancer. A company statement says the ProSense is a minimally invasive cryoablation technology that destroys tumors by freezing
Devices
A 3/6-3/10 FDA inspection at Ming Fai Industrial Co in Guangdong Sheng, China, found Quality System regulation violations in the firm’s manufacturing of ultrasound gel and probe cover products. A just-released 6/1 Warning Letter says the specific violations were: * failing to adequately ensure that