Devices
Repro-Med says that some of the inspection observations from 6/2015 cited in a recent Warning Letter from FDA’s New York District Office had already been resolved to the agency’s satisfaction and three observations require additional clarification. Company officials say they are in the process of addressing
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are asking FDA and HHS officials for information on the progress they have made in adding the unique device identifier (UDI) of medical devices to health insurance claims forms to improve post-market surveillance and curb Medicare waste. Their 3/
Devices
FDA has cleared a Cepheid 510(k) for the Xpert Carba-R, an in vitro diagnostic test for identifying distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP. “The emergence of carbapenemase producing organisms, known as
Devices
FDA has accepted for review a Vericel BLA for MACI (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended for treating symptomatic cartilage defects of the knee in adult patients. The agency has set a user fee review target date of 1/3/2017. Additionally, the company
Devices
FDA is alerting healthcare professionals about magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The agency says it has analyzed peer-reviewed literature, device labeling, adverse event medical device reports, and information from ICD manufacturers, health care organizations,
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Expandable Interbody System for use in spinal disorder surgeries. The all-titanium device is designed to restore disc height, in-situ, during posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and oblique surgical approaches. The company says it allows
Devices
A 6/3-6/23/15 FDA inspection at Repro-Med Systems, Chester, NY found multiple violations in the firm’s work as a specification developer and manufacturer of infusion pumps and intravascular administration sets, according to a 2/26 Warning Letter from the agency’s New York District Office.
Drugs
FDA says it is launching a “lean management process mapping approach to build a better system for combination products review – one that’s more cohesive, more collaborative, and more systematic.” The process begins with an analysis of what’s being done currently, and then it designs a future process state
Devices
FDA has approved a Sensimed de novo marketing application for the Triggerfish, a single-use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP can be associated with glaucoma-related optic nerve damage. The silicone contact lens
Devices
CDRH has approved an alternative standard for using a quality assurance program recommended by the ACR Digital Mammography Quality Control Manual for full-field digital mammography systems. An agency notice says the alternative standard was approved and became effective 2/17, and it can be used by mammography facilities instead
Devices
In a 3/7 email copied to more than 200 FDA leaders, Capitol Hill figures and news media, 792 women told CDRH chief scientist and deputy director William Maisel they are demanding his resignation because they “are outraged that you still believe that Essure is an important, safe, and effective
Devices
FDA has posted a draft guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes” to assist sponsors in evaluating the benefits and risks of devices that target either the cause or progression of a neurological disorder or condition such as Alzheimer’
Devices
FDA has cleared a Stryker Spine 510(k) for its Tritanium PL Posterior Lumbar Cage, an intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease. The device is constructed out of proprietary Tritanium technology and is manufactured using a 3D additive manufacturing process.
Devices
FDA has posted a guidance on “Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails” that provides recommendations on clinical trial designs for devices intended either (1) to provide improvement in the appearance of nails affected by onychomycosis; or (2) to
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the compatibility of the Nexel Total Elbow System with the Comprehensive Segmental Revision System (SRS). The distal component of the SRS humeral system when combined with Nexel is designed for elbow replacement, while the remaining components allow for proximal or
Devices
FDA says that Dräger Medical has expanded its 12/2015 recall of the Evita 500 and Babylog VN500 ventilators to include the PS500 optional battery supply sold for use with the two ventilators. An agency notice says the expanded recall covers power supply units that were updated with new software
Devices
An analysis by the Institute for Critical Infrastructure Technology (ICIT) says that the FDA cybersecurity guidelines for medical device manufacturers are following a “subtle suggestion” approach when regulatory enforcement is needed. In a blog white paper, ICIT says that the argument against enforcing cybersecurity standards typically “centers on the idea
Devices
MedTech Review senior consultant John Beasley says that while there is a three-year transition period for the third edition of the international quality standard for medical manufacturing, ISO 13483:2016, which was published 2/24, medical device manufacturers and their suppliers would be wise to start their transition planning
Drugs
Attorney Jeffrey Gibbs (Hyman, Phelps & McNamara) says that how a therapeutic product is classified profoundly affects how it is regulated, and it is time to reform the FDA mechanism for classifying products. Writing in an online FDLI Update, Gibbs says that the two primary problems with the current system
Devices
Attorney Michelle Yeary says that medical device suits that survive preemption challenges often have difficulty proceeding due to stringent requirements placed on them. Writing online in a Drug and Device Law Blog post, Yeary cites Swisher v. Stryker Corp in which a plaintiff claiming injury from a hip implant asserted
Devices
FDA has cleared a Philips Respironics 510(k) for the Care Orchestrator, a cloud-based clinical management software application for home use that “connects the portfolio of sleep and respiratory care enabling data, clinical management workflow, informatics and intelligence for providers, payers and patients within a single platform,” according to
Devices
Roche has submitted a 510(k) for the cobas c 513 analyzer as a dedicated, high-throughput HbA1c testing solution for people with diabetes. The submission is intended to address the growing prevalence and incidence of diabetes, with projections of 39 million people in the U.S. affected by the