Devices
FDA has published a guidance, FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act, establishing procedures for submitting, reviewing, and responding to requests for information regarding the class in which a medical device has been classified or the requirements applicable
Devices
FDA has approved an Abbott PMA supplement to modify the labeling on its HeartMate 3 left ventricular assist device (LVAD, or heart pump) to eliminate aspirin as part of routine patient management. The company notes that blood thinners have routinely been used by patients receiving LVADs to reduce the risk
Devices
FDA has published a draft guidance, Predetermined Change Control Plans for Medical Devices, with the agency’s current thinking on a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a marketing submission for a device. The document defines PCCPs as the documentation describing
Devices
FDA has given 510(k) clearance to Nanox for its HealthCCSng V2.0 advanced artificial intelligence cardiac solution that helps identify patients at high risk of coronary artery disease. A company statement says the device uses medical imaging data from routine non-gated, non-contrast CT scans that include the
FDA Policy/General
The FDA Bioresearch Monitoring (BIMO) FY 2023 metrics report shows there were 1,073 BIMO inspections across the five FDA Centers. CDER had by far the largest number of inspections at 779, with 141 through CDRH, 126 through CBER, and 26 through CVM. The report also gives common inspection observations
Devices
An 8/20 New York Times investigative article exposes alleged conflicts of interest in retiring CDRH director Jeff Shuren’s regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter, sometimes apparently overlapping into the
Devices
FDA has cleared a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusion. The device comprises a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium,
Devices
The Government Accountability Office (GAO) says FDA has faced challenges in its efforts to establish an active postmarket surveillance system for medical devices. The report identifies these steps that the agency has taken: * establishment in 2016 of a coordinating center to partner with FDA to organize a network of data
Devices
The Association for Molecular Pathology and a doctor described as a “world-renowned clinical pathologist” who chairs the Department of Pathology at the University of Texas Medical Branch-Galveston, are suing FDA in a Texas federal court to block implementation of the agency’s final rule on laboratory-developed tests
Devices
ICU Medical is expanding a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to a manufacturing defect with the batteries, which can result in diminished battery life. The updated notice expands affected products from a 3/2023
Devices
CDRH has granted a de novo marketing authorization for SoClean’s 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunct to reduce bacterial populations on certain compatible home-use continuous positive airway pressure masks and ventilation hoses after cleaning. An agency classification (Class
Devices
FDA has cleared a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation negative pressure wound therapy (NPWT) dressing, NPseal. The surgical dressing uses an integrated pump that establishes and maintains negative pressure with just a few
Devices
FDA has granted a de novo marketing authorization to NOWDiagnostics for its First To Know Syphilis Test, an at-home, over-the-counter test for detecting syphilis (Treponema pallidum) antibodies in human blood. “Results from this type of test alone are not sufficient to diagnose syphilis infection and should be
Devices
FDA has issued iRhythm Technologies (San Francisco, CA) a Form FDA-483 after an inspection last month cited three GMP deficiencies. The company has been working to resolve issues raised in a Warning Letter last year, and the latest inspection presumably is a follow-up action to evaluate the company’
Devices
HHS says it is working with FDA to help resolve an ongoing supply shortage of BD’s Bactec blood culture media bottles, which could impact clinical practices for healthcare providers and laboratories. “We recommend that health care providers, laboratory professionals, and health care facility administrators prioritize and conserve BD Bactec
Devices
FDA has given 510(k) clearance to Cresilon’s Traumagel for temporary external use to control moderate to severe bleeding. A company statement says its plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding in seconds when applied to a wound at the point of
Drugs
The Biotechnology Innovation Organization (BIO) says it is critical that FDA appoint individuals to advisory committees who have the requisite expertise to consider the topics under discussion and provide expert advice to the agency. BIO’s comments are in a letter responding to an FDA request for information and comments
Devices
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Devices
FDA has cleared a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usual care in patients aged 18 and older. The prescription device delivers cognitive behavioral therapy — “evidence-based techniques targeting the cognitive and behavioral factors that
Devices
A 2/15-3/7 FDA inspection at Globus Medical, Inc., in Audubon, PA, found Quality System (QS) and Medical Device Reporting (MDR) violations associated with the firm’s manufacturing of the Class 2 Excelsius GPS surgical robot and associated interbody spine and cranial modules. A just-released 7/15
Devices
FDA has cleared a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty. The device is updated with “enhanced features to support the essential steps of both primary and complex revision arthroplasty,” the company says, adding that it provides surgeons with
Devices
Abiomed is recalling (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection but were inadvertently released to customers. “Using affected pumps may lead to unexpected pump stops or release of potentially harmful particulates,” a recall notice says. “Serious adverse health consequences