Devices
Grail has submitted the final module of its PMA for the company’s multi-cancer early detection blood test. The Galleri test, which was designated a Breakthrough Device by FDA in 2018, is designed to detect cancer signals and predict their tissue of origin from a single blood draw. It
Devices
FDA has issued an updated guidance clarifying when clinical decision support (CDS) software functions fall outside the definition of a regulated medical device, offering developers greater insight into how the agency interprets its statutory authority over digital health tools. The document, Clinical Decision Support Software, which supersedes an identically titled
Devices
As part of its MDUFA 5 commitment to promote international harmonization and provide additional CDRH resources for that work, the Center conducts annual assessments of its international activities. The 2025 report lists the five strategies envisioned in the CDRH strategic plan on international harmonization: * increase engagements in international harmonization, convergence,
Devices
The CDRH 2025 Annual Report says the Center authorized 124 novel medical devices last year, including the first blood test to diagnose Alzheimer’s disease. The report says the number of authorizations was one of the highest in the Center’s more than 40-year history. Other accomplishments cited by
Devices
FDA’s recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home blood collection devices underscores that self-collection kits remain subject to FDA oversight despite a recent court ruling that curtailed the agency’s authority over laboratory-developed tests (LDTs)
Devices
FDA has issued a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subsidiary, Magellan Diagnostics, underscoring an ongoing regulatory focus on the company’s LeadCare products. The 12/22 warning follows an FDA inspection conducted this past summer at Magellan’
Devices
FDA has issued MAST Biosurgery USA a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to the company’s SurgiWrap FROST surgical mesh products. The 12/17 letter says the inspection found that the products were adulterated under federal law because the company
Devices
FDA has approved Guardant Health’s Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) in combination with cetuximab (Lilly’s Erbitux) and chemotherapy. The decision was supported by data from
Devices
FDA has issued a draft guidance laying out detailed expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate their products before seeking market clearance. The document focuses on clinical performance testing for a fast-growing class of devices that estimate blood pressure without
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