Devices
Universal Meditech has recalled (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they were distributed to U.S. customers without FDA authorization, clearance or approval. “Neither Universal Meditech Inc. nor SML Distribution LLC, has provided the FDA with adequate data to show that
Devices
An FDA Office of Criminal Investigations probe has resulted in a 2/1 Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals charging them with “conspiracy and introduction of adulterated and misbranded devices with intent to defraud and mislead, conspiracy to commit mail fraud, and alteration of
Devices
A 5/23-5/26/22 FDA inspection at MicroVention Costa Rica, in Alajuela, Costa Rica, found Quality System regulation violations in the firm’s manufacturing of microcatheters and balloon catheters. A just-released 9/30/22 Warning Letter says specific violations were: * failing to verify a process that cannot
Devices
A 7/18-7/21/22 FDA inspection at Getsch+Hiller Medizintechnik in Nendingen, Germany, found Quality System regulation and other violations in the firm’s manufacturing of monopolar laparoscopic instruments with disposable and reusable instrument tips. A just-released 12/27/22 Warning Letter lists the specific violations as:
Devices
FDA has revised its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users to self-report their test results at MakeMyTestCount.org. The agency says that each test result should be reported only one time, and it
Devices
A citizen petition from the Clinical Decision Support (CDS) Coalition asks FDA to rescind its controversial 9/2022 final guidance on “Clinical Decision Support Software” (see earlier story) because it violates the Federal Food, Drug, & Cosmetic Act (FD&C Act). The group says FDA should repropose the CDS
Devices
FDA has approved an Abbott expanded indication for its FlexAbility Ablation Catheter, Sensor Enabled, a flexible tip catheter intended to help physicians identify abnormal signals and apply therapy to treat ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM). The company says NICM is a type of heart muscle
Devices
A new 2022 annual report on CDRH’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program says it will transition to a permanent program based on demonstrated review efficiencies. ASCA encourages device sponsors to use FDA-recognized voluntary consensus standards in their submissions because they reduce regulatory burden and promotes
Devices
The Department of Justice (DoJ) says medical device manufacturer Joint Active Systems (JAS), of Effingham, IL, has agreed to pay $500,000 to settle civil claims under federal and North Carolina False Claims Acts concerning allegations that it caused submission of false claims to North Carolina’s Medicaid program. DoJ
Drugs
A recent New York federal court dismissal of a dietary supplement preemption case can be instructive for drug and medical device manufacturers. Attorney Stephen McConnell (Reed Smith) writes in an online Drug and Device Law post that the case was one of several around the U.S. that involved plaintiffs
Devices
FDA says the Philips Respironics 8/2/22 recall of certain BiPAP and CPAP masks was Class 1. An agency statement says the company recalled some 18,670,643 units that were distributed in the U.S. between 1/1/15 and 9/9/22. The notice says the company
Drugs
Attorney Amanda Johnston (Gardner Law) says there are five steps leaders of FDA-regulated companies can take to mitigate the risk of Park Doctrine (Responsible Corporate Officer Doctrine) violations. Writing in an online blog post, Johnston says the doctrine “imposes strict, vicarious criminal liability upon responsible corporate officers for misdemeanor
Devices
FDA has approved an expanded indication for Abbott’s FlexAbility sensor-enabled ablation catheter, a flexible tip catheter that the company says helps doctors identify abnormal signals and apply therapy to treat ventricular tachycardia (VT) with non-ischemic cardiomyopathy (NICM). A company statement says its LESS-VT study was the
Devices
FDA has cleared a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures tendons in the foot, ankle, and knee using artificial intelligence (AI). The company says the new device will be available soon with the company’s Clarius L7 HD3 and
Devices
Xenex Disinfection Services has filed a de novo petition for its LightStrike+ ultraviolet (UV) room disinfection technology. The company’s device uses a xenon lamp to create broad spectrum UV light intended to destroy pathogens on surfaces in healthcare facilities. It has been marketed during the Covid-19 emergency under
Devices
FDA says a 6/28-7/8/22 inspection at RightEye, LLC, in Bethesda, MD, determined the firm is promoting its RightEye Vision System, a Class 2 nystagmograph medical device, for off-label uses to improve vision problems and measure and analyze eye movements for “neurological disorders.” A just-released
Devices
FDA has classified as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued “urgent medical device correction” letter identifying two potential issues with CADD Infusion System Infusion Sets due to lack of delivery or underdelivery and false “no disposable attached (NDA)” alarms. A recall notice details
Devices
FDA has posted a final guidance entitled “Surveying, Leveling, and Alignment Laser Products.” The document says that such laser products are used for “determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement; positioning or adjusting parts in proper relation to one
Devices
FDA has classified as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the device hub. “During treatment, this leak could result in mixing of the arterial and venous blood, lead to increased recirculation and
Devices
After 11 years at cloud and computer tech company Oracle, Troy Tazbaz has joined FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May to work for Google Health and its parent company Alphabet as senior director for global health strategy and regulatory
Devices
FDA has announced a new funding opportunity for its Pediatric Device Consortia grants program, which is open for applications through 3/29. Under the program, applicants request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. “The advising and
Devices
LivaNova (TandemLife) has again recalled its LifeSPARC Controller, part of the LifeSPARC extracorporeal system used in heart surgeries, due to a problematic software update that was designed to address a previous software malfunction (see earlier story). The software update was found to create the same problem where the device erroneously