FDA Policy/General
National Center for Health Research president Diana Zuckerman says FDA commissioner Marty Makary’s plan to rely on “spontaneous [and] robust” expert panels rather than advisory committees misses the point on the value of advisory committees and undermines the credibility of agency decisions. Writing in a Medpage Today opinion column,
Devices
FDA has issued an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump (LVP) primary administration sets that could cause dangerous reverse fluid flow and delay critical medication delivery. The issue involves a misassembly in one lot of administration sets in which
Devices
Intersurgical has recalled (Class 1) its i-View Video Laryngoscope, citing serious safety risks that could potentially lead to severe injury or death. The recall affects devices with model number 8008000 and serial numbers 1240555 and 1240793. The recall was prompted by reports that the devices may fail to turn
Devices
FDA has issued a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with the Bunnell LifePulse High Frequency Jet Ventilator and possibly other conventional ventilators. The agency warned that the problem can interrupt nitric oxide therapy and
Devices
FDA says the 8/22 Medline recall of three models of sterile medicine convenience kits is Class 1. An agency notice says the company contacted five customers on 8/8, telling them to hold any kits in their possession. A formal recall notice followed on 8/22, the agency says.
Devices
Siemens Healthineers has issued an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastrophic failure involving the systems’ magnet venting pathways. The alert covers many of the company’s high-field MRI systems, including MAGNETOM Verio, Skyra, Prisma, Vida, Lumina,
Devices
Aesculap Implant Systems has agreed to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee replacement implants and provided unlawful kickbacks to a surgeon. The Pennsylvania-based medical device company also entered into a non-prosecution agreement for distributing two
Devices
FDA has denied a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures may interfere with breast cancer detection using mammography or ultrasound. In an 11/14 denial letter, FDA said it has found no evidence of a safety signal linking
Drugs
NYU Grossman School of Medicine ethicist Arthur Caplan says he is concerned that reductions in force at FDA and HHS can adversely affect clinical trial oversight and participant protections. In a Medscape video, Caplan says, “I am extremely worried about what’s been taking place at FDA and at HHS
Devices
Based on the discussion at an FDA Digital Health Advisory Committee public meeting on “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,” five Orrick attorneys say that manufacturers developing large language model-based prescription therapies for major depressive disorder “should anticipate a risk-based, lifecycle regulatory approach.” In an
Devices
FDA has approved Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite stable endometrial carcinoma who may benefit from treatment with Merck’s Keytruda (pembrolizumab) in combination with Eisai’s Lenvima (lenvatinib). The polymerase chain reaction-based assay is designed to determine microsatellite
Devices
Three Alston & Bird attorneys say that complying with FDA’s forthcoming Quality Management System Regulation (QMSR) is not just a regulatory obligation but a critical business strategy. Writing in a detailed Drug & Device Advisory, the attorneys discuss FDA’s 10/27 draft guidance describing the Quality Management System
Devices
FDA has given investigational device exemption (IDE) approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) procedure using the company’s proprietary radiofrequency vapor ablation (RFVA) system. A company statement says FDA has already granted the system a breakthrough device designation to treat adults
Devices
FDA has issued an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement system continues to demonstrate a higher-than-expected risk of device failure, with revision rates increasing significantly over 10 years of follow-up. According to a final post-
Devices
FDA has cleared a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer, the HLC-723 GR01, for rapid and precise HbA1c (blood sugar) testing. The new system can deliver results in as little as 50 seconds, supporting both diabetes diagnosis and long-term glucose monitoring, according to
Devices
A 6/30-7/3 FDA inspection at Qinjiang Kingphar Medical Material Co. in Qinjiang, China, identified two Quality System Regulation violations in the firm’s manufacturing of surgical masks, wound dressings, sterilization wraps, and surgical drapes. A 10/3 Warning Letter says the specific violations were: * failure to establish
Devices
A 6/9-6/12 FDA inspection at Centec Medical Systems in Qinhuangdao, China, found Quality System Regulation and other violations in its production of several medical devices. A 10/2 Warning Letter says the specific violations were: * failure to adequately establish procedures for corrective and preventive action; * failure to
Devices
FDA inspections at three Royal Philips medical device manufacturing facilities — Bothwell, WA, Reedsville, PA, and Eindhoven, Netherlands — identified Quality System Regulation and other violations in the firm’s manufacturing of several medical devices. A just-released 9/9 Warning Letter says the specific violations were: * failure to establish and maintain
Devices
Warning Letters sent recently by FDA to two medical device companies instructed the firms to respond within 30 days, rather than the typical 15 days. Three Hyman, Phelps & McNamara attorneys write in their firm’s FDA Law Blog that their review of some 200 Warning Letters issued by CDRH
Devices
FDA has published a draft guidance, Menstrual Products—Performance Testing and Labeling Recommendations, with the agency’s recommendations for performance testing and labeling of such products, and also information for inclusion in 510 (k) submissions, when necessary, for certain menstrual products. The document says its recommendations apply to tampons, pads,
Devices
FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System (QMS) information to include in premarket submissions. The agency says the document is intended to help companies prepare and maintain a QMS and provide sufficient information for FDA to assess compliance with
Devices
FDA has cleared a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterization labs by eliminating the need for costly capital equipment. The platform, which YorLabs describes as the first “zero-CapEx” intracardiac echocardiography (ICE) solution, delivers real-time, high-resolution