FDA Policy/General
In an amicus brief filed with a Massachusetts federal court, the Medical Information Working Group asks that the court address concerns that FDA enforcement policy is not consistent with 1st and 5th Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about product off-label uses.
Devices
FDA has cleared a GI View Ltd. 510(k) for its new Aer-O-Scope Colonoscope System, a disposable, self-propelled, joystick-controlled, colonoscope that features therapeutic access. “The new system has two working channels that enable therapeutic access using standard tools, such as snares and forceps, to take biopsies
Devices
Sen. Lamar Alexander (R-TN) says that an FDA proposal to regulate laboratory-developed tests amounts to “double regulation” since the tests are already regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratories Improvement Act. At a Senate Health Committee hearing on the proposal, Alexander said
Devices
FDA has cleared a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System. The company says this clearance enables the screw and connector components to be used as a part of a growing rod construct designed to accommodate growth
Devices
FDA has cleared a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provide a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant
Drugs
FDA has issued for comment a draft guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug sponsors and medical device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of the products such
Devices
FDA has issued a guidance, Reporting of Computational Modeling Studies in a Medical Device Submission, with recommendations for industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies used to support medical device submissions. The document says its recommended format aims to
Devices
CDRH says its 10 FY 2017 regulatory science priorities will be a “catalyst to improving the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products” and will facilitate introducing innovative medical devices into the marketplace. The priorities will be reassessed and updated periodically to reflect current regulatory
Devices
Attorney James Beck (Reed Smith) says that causation in failure-to-report claims is necessarily roundabout because, as the 9th Circuit Court of Appeals held in 2013, “any attempt to predicate the claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Writing in
Devices
FDA has cleared a Life Spine 510(k) for the PRO-LINK Ti Stand-Alone Cervical Spacer System, a stand-alone cervical interbody that is made using the company’s Osseo-Loc technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which is
Devices
FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies — a Synchrony cochlear implant that stimulates the auditory nerve for high-frequency hearing loss, and the Sonnet EAS audio processor, with built-in acoustic amplification for low-
Devices
FDA has approved Bayer’s Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system for preventing pregnancy for up to five years. Kyleena is a small, flexible plastic T-shaped device containing levonorgestrel 19.5 mg. It is placed by a healthcare provider during an in-
Drugs
HHS has issued a new rule and the National Institutes of Health (NIH) has issued a new policy, both of them intended to increase the availability of clinical trial information and data on clinicaltrials.gov, which is run by NIH. The final rule applies to “responsible parties,” a clinical trial
Drugs
FDA is working with stakeholders to revisit criteria used for determining whether a patient is eligible to participate in a trial, according to Oncology Center of Excellence (OCE) acting director Richard Pazdur in a new blog posting. “Modifying the eligibility criteria could expand the number of people who qualify and
Devices
FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The device allows a physician to use a catheter
Devices
FDA has approved a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon approved to treat in-stent restenosis in the U.S. Approval was based on data from the IN.
Devices
Varian Medical Systems has received 510(k) clearance to market the Nexus DR, a high resolution system for X-ray imaging using a digital X-ray detector. The device is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications, according to the company. The
Devices
Attorney Cliff Rieders (Rieders, Travis) says the Supreme Court has laid out several types of state law tort claims about medical devices that are preempted by federal law. In a Legal Intelligencer blog post (free subscription required) that traces medical device preemption relating to products approved through PMAs and 510(
Devices
CDRH has denied a Germaine Laboratories petition that sought an exemption from premarket notification requirements for “method, metallic reduction, glucose (urinary, non-quantitative)” devices that are in reagent tablet form. Currently, the devices are in Class 2 and referred to as “copper reduction tablet tests.” The devices are intended for
Devices
FDA has granted EBR Systems an Investigational Device Exemption for its WiSE (Wireless Stimulation Endocardially) technology for cardiac resynchronization therapy (CRT). The company says it is now planning a major U.S. study to establish safety and effectiveness data to support FDA approval. The company says about 30% of patients
Devices
FDA has approved a Carl Zeiss Meditec PMA for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. The device removes a small amount of eye tissue to permanently reshape the cornea, according to
Devices
A former medical device sales representative for Johnson & Johnson was convicted by a Florida federal court jury on seven felony counts of conspiring to transport stolen medical devices in interstate commerce, money laundering, and other charges. The Department of Justice says that the conviction of Kerri Kaley arose out