Devices
FDA has appointed former Anika Therapeutics chief scientific officer John Sheets as CDRH Office of Device Evaluation director effective 6/1. Sheets replaces former director Christy Foreman, who stepped down in 2014 to accept a new position at FDA’s Center for Tobacco Products. CDRH’s deputy director for science
Devices
The federal government has filed an amicus brief with the 1st Circuit Court of Appeals to argue the position that “fraud in the inducement” is a potentially viable theory of False Claims Act (FCA) liability. The brief was filed in an appeal of a Massachusetts federal court whistleblower suit against
Drugs
The National Institutes of Health (NIH) says that its new Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research “sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.
Devices
A 11/30/15-2/12/16 FDA inspection at Tyrx, Inc., Monmouth Junction, NJ, found Quality System Regulation violations in the firm’s manufacturing of the Tyrx antibacterial envelope, Tyrx antibacterial absorbable envelope, and the Tyrx neuro antibacterial absorbable envelope, according to a 6/2 Warning Letter from the
Devices
A Health Affairs blog article suggests that FDA take a similar regulatory approach to the one it uses to oversee hearing aids for the emerging market of mobile health apps and wearables. For hearing aids, a product may be unregulated (e.g., personal sound amplification products) or regulated as a
Devices
FDA has granted Hologic an emergency use authorization for its new diagnostic assay for Zika virus infection, the Aptima Zika Virus assay. The molecular diagnostic tool allows for the qualitative detection of RNA from Zika virus in human serum and plasma specimens, according to the company. The assay runs on
Devices
FDA has released a final guidance on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” that seeks to provide clarity and predictability for device sponsors on specific criteria that should be considered when deciding whether leveraging existing clinical data to support pediatric claims is appropriate. When
Devices
FDA has approved a Medtronic IDE for a pivotal study called SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy). The study is designed to support the expanded indication of currently marketed Visualase MRI-Guided Laser Ablation Technology for treating epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE)
Devices
Ariad Pharmaceuticals has submitted an NDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, seeking approval for use in patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. FDA earlier granted the therapy breakthrough therapy and orphan drug designations for this patient population. The
Devices
FDA has cleared a REBIScan 510(k) for the Pediatric Vision Scanner, a handheld device designed to help physicians screen for amblyopia (lazy eye) and strabismus (misaligned eyes) in young children, as early as preschool age when the condition is easiest to treat. Amblyopia and strabismus are the leading cause
Devices
FDA has released a draft guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” that provides recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups. “Proper evaluation and reporting of
Devices
FDA has cleared a SpineGuard 510(k) for the PediGuard Threaded DSG device for use in pedicle screw insertion. “A single-use DSG pin embedded with the bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the single-use DSG handle.
Devices
FDA has accepted and reviewed a Spectral Medical pre-clinical module for Toraymyxin, an investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the company says it remains on track to complete its full PMA submission by the end of the year. “This particular
Devices
FDA has cleared a Meridian Bioscience 510(k) for a new molecular diagnostic test for Mycoplasma pneumonia. The Illumigene Mycoplasma Direct assay features a simplified three-step procedure that provides definitive results in less than one hour, the company says. Often referred to as “walking pneumonia,” M. pneumoniae is associated
Devices
FDA clears a Tyber Medical 510(k) for its headed and snap-off screw systems, indicated for use throughout the extremities in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation appropriate for the size of the device. The cannulated headed screws (available in 1.5mm-9.0mm)
Devices
FDA has issued a draft guidance, Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, to clarify for industry and agency staff the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and
Devices
Two new warnings are included among revisions Boston Scientific has made to the directions for use for six stress urinary incontinence products. A company announcement says that the first warning states that mesh is considered a permanent implant and removal of mesh or correction of mesh-related complications may involve
Devices
FDA has accepted an Allergan 510(k) for the XEN Glaucoma Treatment System (comprising the XEN45 Gel Stent and the XEN Injector). The implantable crosslinked gelatin shunt is intended for use to reduce intraocular pressure associated with refractory glaucoma, according to the company. The device is CE marked in the
Devices
FDA has posted a guidance on “Use of International Standard ISO 10993-1 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.” The agency says the document is intended to assist industry in preparing marketing submissions for medical devices that come into direct or
Biologics
FDA has issued a final rule to explicitly allow for optional inclusion of standalone symbols without adjacent explanatory text in labeling for medical devices and certain biological products if certain conditions are met. The rule also specifies that using symbols, accompanied by adjacent explanatory text, continues to be permitted. The
Devices
FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short
Devices
Haemonetics has recalled three lots of its Leukotrap RC System with RC2D Filter due to reports that white blood cell counts were higher than expected during collection. The device is a closed system for collecting one unit of whole blood and the pre-storage leukoreduction of packed red blood cells