Devices
An FDA inspection at Tosoh Bioscience, Grove City, OH, on various dates between 5/16 and 6/28 found Quality System Regulation violations in the firm’s work as the initial importer, complaint handling unit, and repacker/relabeler of high performance liquid chromatographs used in measuring hemoglobin, automated immunoassay analyzers
Devices
FDA has posted a final guidance on “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” that outlines the principal factors it considers when making such determinations during the premarket review process for certain medical devices. The document is intended to improve
Devices
FDA has classified as Class 1 a recall involving Alere’s INRatio 2 PT/INR Home Monitoring System for warfarin therapy. Last month, the company said it was initiating a voluntary withdrawal of its controversial device due to concerns about inaccurate test results. Last year, Public Citizen reported that the
Devices
FDA’s newly issued draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications has special meaning to lawyers representing companies in product liability lawsuits, according to Reed Smith lawyer James Beck. In a new blog post, Beck welcomes the
Devices
FDA has approved an ImPACT Applications de novo petition to allow the marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices approved
Devices
FDA has cleared an Alere 510(k) for its Alere i RSV test for detecting respiratory syncytial virus (RSV) infection in children and adults. The test comes on the heels of the Alere i Influenza A & B and Alere i Strep A, and they all run on the Alere
Devices
FDA’s Microbiology Devices Panel has unanimously agreed that the benefits outweigh the risks for allowing over-the-counter (OTC) diagnostic tests for detecting Chlamydia trachomatis/Neisseria gonorrhoeae. The panel also agreed that benefits outweighed risks for OTC group A streptococcus tests. However, the panel did not come to an
Devices
CDRH has updated its Web page on requests for an exception to use an alternative approach to meet requirements under the agency’s Unique Device Identifier (UDI) rule. According to the agency, a device labeler may submit a request for an exception from or alternative to the requirement for the
Devices
FDA has approved an expanded indication for Edwards Lifesciences’ Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk
Drugs
The National Institutes of Health (NIH) says that a recent survey found that many respondents would be willing to participate in the national Precision Medicine Initiative (PMI) Cohort Program, a longitudinal research program that aims to enroll one million or more U.S. residents to improve the ability to prevent
Devices
Medtronic has notified healthcare professionals about the potential for vascular trauma with the use of its EnVeo R Delivery Catheter System. The company says that while the reports of vascular trauma it has received have been infrequent, they have included serious outcomes, including 19 patient deaths. The observed rate of
Drugs
Attorney Jennifer Newberger (Hyman, Phelps & McNamara) says that a new pre-RFD (Request for Determination) process announced by the FDA Office of Combination Products (OCP) to provide a more interactive approach to product designation should be “unsettling” to any sponsor who has dealt with OCP. Writing in her firm’
Devices
Kentucky’s attorney general says the state has filed a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its allegedly deceptive marketing of surgical transvaginal mesh. “In Kentucky, more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient
Devices
FDA has cleared a Levita Magnetics 510(k) for its Levita Magnetic Surgical System that is intended for use to magnetically retract and maneuver the gallbladder, reducing the number of surgical incisions. The device is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic
Devices
Commenting on an FDA draft guidance on categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions, AdvaMed says it supports CMS coverage of all IDE trials. The comment letter says that in recent years CMS declined to cover only
Devices
FDA has published a guidance, Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, to make recommendations to establishments that make donor eligibility determinations on using FDA-licensed nucleic acid tests (NAT)
Devices
FDA is recommending that health care facilities stop using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for reprocessing duodenoscopes because of inadequate reprocessing validation and performance data. An agency safety notice says the reprocessors remain available to reprocess other flexible endoscopes. FDA says it continues to work closely
Devices
An 11/9/15-11/11/15 FDA inspection at Helica Instruments, Edinburgh, United Kingdom, found multiple Quality System Regulation violations in the firm’s production of an electrosurgical cutting and coagulation device and accessories, including the Helica Thermal Coagulator. A just-released 5/13 Warning Letter says that violations
Drugs
The FDA Group says that to prevent potentially damaging consequences when things go wrong, manufacturers need to take on effective remediation projects that not only identify the root causes of particular problems, but put comprehensive plans in place to remedy them and communicate the improvements to FDA effectively. In a
Devices
FDA has cleared a Centric Medical 510(k) for the Tarsa-Link Bunion Correction System. The device features an “opening base wedge with built-in fixation” for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma treatments, according to the company. “In past opening base wedge osteotomies, a plate
Devices
Commenting on an FDA draft guidance on dissemination of patient-specific information from medical devices, the Patient, Consumer, and Public Health coalition says that information communicated to patients should be done in a manner that is easy for them to understand. The coalition also says it agrees with the agency
Devices
FDA has cleared a Bovie Medical 510(k) for its PlazXact bipolar ablator, a surgical tool designed to improve a surgeon’s precision and safety when performing arthroscopic procedures. The clearance covers the device’s cutting, vaporization and coagulation of soft tissue during arthroscopic surgical procedures, while operating with a