Devices
FDA has cleared a Meridian Bioscience de novo submission for a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital
Devices
FDA has issued two draft guidances on blood glucose monitors used in home and healthcare settings. When finalized, the guidances will replace those issued in 2016 to provide more clarification on design considerations and recommended standards as requested by stakeholders. The first draft, Blood Glucose Monitoring Test Systems for Prescription
Devices
FDA has approved an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros ECi/ECiQ Immunodiagnostic Systems. The HIV combo test was previously approved for use on Ortho’s Vitros 5600 Integrated System and Ortho’s Vitros
Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for preventing cluster headaches in adult patients. The clearance was supported by data from two studies, including PREVA (PREVention and Acute treatment of chronic cluster headache), a prospective, open-label,
Devices
FDA has published a draft guidance, Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, to implement a section of the 21st Century Cures Act requiring the agency to revise Section V, “Demonstrating Insignificant Risk of Erroneous Result—
Devices
FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway. The document describes study designs for generating data that support both 510(k) clearance and CLIA waiver. The
Devices
FDA has cleared a Mesa Biotech 510(k) for its Accula RSV test, a respiratory syncytial test cassette for diagnosing both children and adult populations. The Accula RSV test is the second molecular point-of-care diagnostic on the Accula platform to receive FDA clearance and follows the company’s
Devices
FDA has classified as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and the SpF-XL IIb 2/DM Implantable Spinal Fusion Stimulator due to a lack of adequate validation and controls to ensure
Devices
Former FDA associate commissioner Peter Lurie, who now heads the Center for Science in the Public Interest, is expressing concern that with its emphasis on being “first” in medical device approvals and acting on safety signals, FDA is laying the groundwork for a “sliding scale” of medical evidence that will
Devices
FDA has declined a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musculoskeletal pain. “In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a
Devices
FDA has released a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/2017 Patient Engagement Advisory Committee meeting. The agency notes that device clinical trials designed with patient input may be more likely to enroll and retain patients, collect
Devices
FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve device safety or performance and to “retire” outdated predicate devices that have been cited to demonstrate equivalence, “especially in cases where we’ve seen
Devices
FDA has classified as Class 1 an Oscor recall of its TB Temporary Bipolar Pacing Leads due to connector separation that may cause a loss of pacing. The TB Leads are used by physicians to stimulate or pace the heart to increase heart rate. Temporary pacing leads are placed into
Devices
The Medical Imaging and Technology Alliance says that it believes that FDA relied on inadequate data collection in reaching some of its conclusions in a report on the quality, safety, and effectiveness of servicing of medical devices. “It is impossible to provide a statistically valid analysis of the extent of
Devices
AdvaMed has submitted its comments to FDA on the agency’s draft guidance on consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals. The association provided FDA specific line-by-line comments.
Devices
CDRH has released a Medical Device Enforcement and Quality Report it says demonstrates that increased inspections of medical device manufacturers and a targeted risk-based approach leads to improved compliance. “As medical device manufacturing has become an increasingly global enterprise,” says CDRH director Jeffrey Shuren, “FDA has taken forceful action
Devices
A 9/18-10/2 FDA inspection at American Contract Systems, Zelienople, PA, found Quality System Regulation violations in the firm’s operations as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. An 11/6 Warning Letter says specific violations were: * failing to
Devices
In a joint statement, FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say they have a new medical device safety goal: to ensure that FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. Their statement also discusses
Devices
FDA says a Beckman Coulter recall of its FC 500 and EPICS XL series flow cytometers is Class 1. An agency recall notice says the devices are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. They can be used to
Devices
FDA has cleared a SIG Medical 510(k) for its AdvantageRib Anterior System, intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone. The device contains titanium plates and screws to treat rib fractures through a traditional anterior approach, according to the company.
Drugs
FDA is seeking input on how it can promote the development of digital technologies that would guide safe and effective prescription drug use to help patients improve their health. “As part of this process, we’re seeking input from the public on new steps to modernize our approach to overseeing
Devices
Three King & Spalding attorneys say the “unavoidably unsafe” exception in a comment in a section of the Restatement (Second) of Torts should be categorically applied to all medical devices. Writing in a Washington Legal Foundation (WLF) Legal Opinion Letter, the attorneys say the Utah Supreme Court will soon have