Devices
FDA has issued an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra LifeSciences, citing packaging failures that could compromise product sterility and lead to patient infections. The alert covers all MediHoney Wound and Burn products and select lots of CVS
Devices
Advanced Medical Technology Association (AdvaMed) is urging FDA to narrow and clarify a draft guidance on quality management system information, warning that the current proposal could add unnecessary burden and confusion to the premarket review process. In just-posted comments, the group said FDA’s recent draft guidance on Quality
Devices
FDA is alerting healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantive warned that a key component may become dislodged during treatment. In an agency early alert, Vantive is said to have notified customers that updated use instructions are needed
Devices
FDA has cleared a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast biopsies across multiple imaging modalities. The company says the device is intended to support the diagnosis of breast disease by giving providers greater
Devices
FDA has cleared an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system, allowing its use in children as young as four years old. The device is designed to standardize and precisely control the insertion of cochlear implant electrodes, a step surgeons
Devices
A 7/18-8/1/2025 FDA inspection at ASP Global, doing business as Anatomy Supply Partners in Austell, GA, found multiple violations in the firm’s manufacturing of the Safe-T-Fill Micro Capillary Collection System. A just-released 12/9/2025 Warning Letter cited these specific Quality System
Drugs
The National Security Commission on Emerging Biotechnology (NSCEB) says FDA’s oversight of medical products through CBER, CDER, and CDRH “has largely been successful for traditional products but is increasingly inefficient when applied to innovative medical products.” In a report, “Modernizing Medical Biotechnology Regulation,” NSCEB says FDA regulatory frameworks were
Devices
AVID Medical has recalled (Class 1 device correction) certain organ recovery and medical convenience kits, warning that continued use of a non-medical-grade component could lead to serious injury or death. According to an agency notice, AVID Medical identified that 24-by-30-inch poly bags included in certain
Devices
Among the topics discussed at the 12/11/2025 FDA/Industry MDUFA 6 Reauthorization Meeting were the FDA perspective on reauthorization involving real-world evidence (RWE) and the agency’s perspective on reauthorization of the 510(k) total time to decision (TTD) goal and methodology. According to the meeting minutes,
Devices
FDA has published two final digital health guidances. The first, General Wellness: Policy for Low Risk Devices, clarifies CDRH’s compliance policy for low-risk products that promote a healthy lifestyle. The document does not apply to products regulated by other FDA Centers or to combination products. The guidance includes
Devices
FDA says the Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Class 1. An agency notice says the notice only affects users of version 1.15.0 of the Android U.S. app. The notice says Dexcom made the correction
Devices
FDA is announcing a 1/14 town hall to discuss its Quality Management System Regulation (QMSR), particularly how it addresses medical device risk management, risk-based approaches, risk-based decisions, and design and development. The Medical Devices Quality System Regulation Amendments final rule was published on 2/2024, with an
Devices
FDA says it has begun enforcement actions against companies illegally marketing breast binders to children, placing the agency’s role at the center of a broader federal crackdown announced by HHS on what it calls sex-rejecting medical procedures for minors. The agency says it is issuing Warning Letters to
FDA Policy/General
Two Mintz attorneys say a recent FDA announcement that it has deployed agentic artificial intelligence (AI) raises concerns for regulated industries. Writing in their firm’s online newsletter, Joanne Hawana and Benjamin Zegarelli say agency officials predict that integrating agentic AI into regulatory workflows will lead to greater efficiency and
Devices
FDA has published a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, clarifying how the agency evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for
Drugs
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for (1) increasing the enrollment of females in clinical trials and non-interventional studies; (2) analyzing and interpreting sex-specific data; and (3) including sex-specific information in regulatory submissions of
Devices
The Government Accountability Office (GAO) is urging HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how the agency oversees medical device recalls, including lengthy delays in formally closing recalls of high-risk products. In a just-released report, GAO found that FDA
Devices
The American College of Cardiology has joined the American Medical Association, the College of Healthcare Information Management Executives, and many other healthcare organizations in opposing a proposed change to U.S. cybersecurity policy. Cardiovascular Business reports the proposal, first developed under the Biden administration, claimed it would “better protect the
Devices
An Eagle Hill Consulting independent assessment of FDA’s Total Product Lifecycle Advisory Program (TAP) pilot found it “demonstrates exceptional performance across all key metrics, indicating strong progress toward achieving its outcomes.” The conclusion is in the 12/2025 Final Assessment Report, based on information from 95 TAP innovators and
Devices
FDA has approved the first at-home, prescription-only brain-stimulation device to treat major depressive disorder. Flow Neuroscience says its FL-100 system, a transcranial direct current stimulation (tDCS) device, is designed for adults with moderate to severe depression. It is intended as a stand-alone intervention or as
Devices
Rep. Jan Schakowsky (D-IL) and Sen. Dick Durbin (D-IL) have reintroduced legislation they say will improve the medical device recall process to protect patients. In a statement, Schakowsky says the Medical Device Recall Improvement Act would: * require FDA to establish an electronic format for medical device recall notifications;
Devices
FDA has cleared a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults (ages 22 to 55) with attention-deficit/hyperactivity disorder. The mobile app adapts 13 cognitive training games into a regulated therapeutic module designed to target cognitive processes tied to attention.