Devices
FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with a requirement for a single electronic format submission. A Federal Register notice to be published 9/13 says the proposal, if finalized, would improve the agency’s premarket submission
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FDA has awarded five grants totaling up to $6 million per year for the next five years to pediatric device consortia across the country to provide advice and support services to innovators of children’s medical devices. An agency news statement says the program “aims to enhance the development, production,
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FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say that as part of the agency’s FY 2019 budget they are proposing to create a Center of Excellence for Digital Health to advance modernizing FDA’s regulatory approach to help the industry grow and reach its full potential while
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FDA inspections at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico, and Medtronic’s Cardiac Rhythm and Health Failure business, Mounds View, MN, found violations of FDA regulations, according to Warning Letters sent to each facility. The 8/23 Puerto Rico Operations Warning Letter says investigators found Quality System regulation
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The HHS Inspector General (IG) says FDA should promote use of presubmission meetings to address cybersecurity-related questions, include cybersecurity documentation as a criterion in the agency’s Refuse-to-Accept checklist, and include cybersecurity as an element in its “Smart” template. The recommendations are in a study report that
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Cook Medical has received an FDA close-out letter resolving a 2014 Warning Letter for processes related to the company’s quality system at its manufacturing facility in Bloomington, IN. The Warning Letter from the Detroit District Office said that violations noted in the inspection included: * failing to validate, with
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After years of FDA resistance, CDRH officials have agreed to meet 9/13 with injured LASIK patients seeking an agency ban on the vision-correction indication for the ophthalmic lasers used in the procedure. The group is being led by former CDRH branch chief Morris Waxler, who approved the LASIK
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FDA has cleared a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and neonatal patients. Previously, RAM was cleared to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. “With clearance of
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FDA has cleared a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing
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CDRH Office of Device Evaluation director William Maisel says the agency is concerned by continued reports of misconnections with enteral devices. In a letter to enteral feeding tube manufacturers, healthcare professionals, and hospital purchasing departments and distributors, Maisel says FDA recommends that hospitals and clinicians use enteral devices with connectors
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FDA has cleared an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex retina laser systems and is worn on the physician’s head. “The product combines a laser treatment beam from an Iridex laser source with the
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FDA has cleared an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation. The device, indicated for use with the Smith & Nephew Taylor Spatial Frame, reduces the time and effort involved in manual input of measurements and their values as required by currently available
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Ohio State University assistant professor of physical medicine and rehabilitation Lynne Gauthier has petitioned FDA to expand 510(k) exemption status to all small and portable sensors that can be used for relaxation of muscular reeducation. The petition says that new sensors have recently become available that provide the same
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Intuitive Surgical has submitted a 510(k) for the company’s new flexible robotic-assisted, catheter-based platform, which is designed to navigate through very small lung airways to reach peripheral nodules for biopsies. The device is intended to address the majority of suspicious lesions found in the lung that
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FDA has issued a draft guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, describing the agency’s current approach to considering uncertainty in making benefit/risk determinations for some medical device applications. “FDA believes the approach described
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CDRH has released a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” The document describes FDA’s current approach to this topic. FDA says its approach is tailored to the type and intended use of
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FDA commissioner Scott Gottlieb says that CareFirst BlueCross BlueShield and United Health Group have joined the agency’s Private Payor Program to participate in medical device manufacturer pre-submission meetings. In an FDA Voice blog post, Gottlieb writes that the program is a “voluntary opportunity for manufacturers to receive feedback
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FDA has cleared a Captiva Spine 510(k) for its TirboLOX-L 3D-Printed Titanium Lumbar Cages. The device is features a dual layer organic lattice structure, according to the company. “This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture,” it says. “Titanium alloy
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FDA says it is launching a Quality in 510(k) (Quik) Review Program pilot for some moderate-risk medical devices. The program will allow sponsors of certain moderate risk medical devices to use the FDA eSubmitter software to structure their 510(k) applications for submission to the agency. An agency
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FDA says the 6/20 Vyaire Medical recall of 2,150 units nationwide of its Tri-Flo Subglottic Suction System due to risk of device breakage is a Class 1 recall. An agency notice says the units were distributed between 1/23 and 5/23. The notice says that healthcare
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Helius Medical Technologies has submitted a de novo clearance request for its Portable Neuromodulation Stimulator (PoNS) device for treating chronic balance deficit due to mild-to-moderate traumatic brain injury. The submission is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device’s safety
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Compass Health Brands has recalled its continuous positive airway pressure (CPAP) mask cushion seals due to possible air leaks. The replacement seals are used with the firm’s Probasics Brand Zzz-Mask SG Full Face CPAP Mask and had a design change that causes them to be incompatible with the