Devices
Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) are asking the Government Accountability Office (GAO) to update its 2011 report recommending that FDA enhance its oversight of medical device recalls. The senators say an update is needed in light of the dramatic increase in overall device recalls, especially
Devices
AdvaMed is raising issues with FDA’s 9/2023 issuance of three “impactful and cross-cutting draft guidance documents related to the 510(k) program.” In its comment on the CDRH FY 2024 proposed guidance development document, the association notes that FDA said the guidances were developed in response to
Devices
Utah-based medical device company Dolor Technologies has entered into a settlement agreement with the U.S. government to resolve Dolor’s civil liability relating to a device it sold for treating migraines. “This resolution requires Dolor to make monetary payments to the U.S. based upon its ability to
Devices
Although the revised FDA unified agenda shows that a final rule on laboratory-developed tests may be published in 4/2024, attorney Allyson Mullen (Hyman, Phelps & McNamara) questions whether the agency can be ready by then. Writing in her firm’s FDA Law Blog, Mullen cites the time FDA
Devices
FDA has approved a ReShape Lifesciences PMA supplement for the company’s next-generation Lap-Band 2.0 FLEX, an implant indicated for weight reduction in patients with obesity. “Compared to our current Lap-Band, the Lap-Band 2.0 has a new feature called FLEX Technology, which acts as
Devices
Former Decision Diagnostics (DECN) CEO Keith Berman (Westlake Village, CA) has pleaded guilty to securities fraud, wire fraud, and obstruction of an official proceeding in connection with his 2020 scheme to defraud investors by falsely telling them FDA clearance was imminent for a blood-based Covid-19 test. According to
Devices
Getinge has recalled its CardioHelp Emergency Drive due to a possible blocking or impairment of the emergency crank. CardioHelp is intended to help oxygenate blood and remove carbon dioxide from it. “It moves blood through a circuit outside the body to support the heart and lungs for up to six
Devices
Cardinal Health has recalled its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. The recall is based on last month’s Nurse Assist, LLC recall of the
Devices
FDA has cleared a Becton Dickinson 510(k) for what it describes as a “novel blood collection device” that gathers blood samples from a fingerstick that produces lab-quality results for some of the most commonly ordered blood tests. “The BD MiniDraw Capillary Blood Collection System is less invasive than
Devices
A lengthy, deeply-researched article released by the investigative newsroom ProPublica and the Pittsburgh Post-Gazette faults FDA for failing to use its power to protect millions of people who were using tainted Philips Respironics CPAP machines and ventilators. While FDA maintains that it acted as soon as it learned
Devices
FDA has opened its eSTAR electronic submission template for voluntary use for certain PMA submissions. The agency says the eSTAR interactive PDF form is intended to guide applicants through preparing a comprehensive medical device submission. “eSTAR is intended to enhance the incoming quality of submissions for a wide range of
Devices
Three medical device industry stakeholders are raising multiple concerns about an FDA draft guidance on best practices for selecting a predicate device to support a 510(k) submission. The Medical Device Manufacturers Association (MDMA) says the draft appears to reflect an evolution from the agency’s approach to the 510(
Biologics
A panel presentation at the 2023 AFDO/RAPS Healthcare Products Collaborative stressed the positive role FDA Project Jurisdiction Officers (PJO) play in coordinating the consideration of combination products. “The PJO is your best contact if you know, or think you know, your product’s Center or if you already have
Devices
FDA has granted ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients living with unresectable hepatocellular carcinoma (HCC). The company recently initiated enrollment in Route90, its pivotal, prospective, multicenter trial to establish the safety and efficacy of Eye90 microspheres in the patient
Devices
FDA has cleared a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device. It is intended to serve as a connection between a 50, 100 or 250ml intravenous (IV) bag, vial with 13mm closure, and an external IV administration set. “The integrated vial adapter makes it possible
Devices
Eitan Medical has recalled its Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues that may fail to detect air in the line when running on battery power. “In some cases, the pump may not sound an alarm when there is air
Devices
Becton Dickinson’ Carefusion unit is recalling (Class 1) its Alaris Infusion Pumps due to compatibility issues with Cardinal Health Monoject syringes. “The Alaris pumps are validated for use with ‘Monoject’ syringes and list ‘Monoject’ as one of the options when the user is selecting a syringe type within the Alaris
Devices
FDA says it is evaluating the potential for device failures such as leaks, breakage, and other problems involving plastic syringes made in China. An agency safety communication says FDA is collecting and analyzing data to evaluate plastic syringes made in China for injecting fluids into or withdrawing fluids from the
Devices
FDA has given 510(k) clearance to GE Healthcare’s Critical Care Suite 2.1 featuring a pneumothorax (PTX) algorithm for the detection, notification, triage, and diagnosis of PTX. The company says the updated PTX algorithm expands the suite’s on-device triage capabilities by providing immediate notification of the
Devices
AdvaMed says it appreciates FDA efforts to develop a draft guidance to help support a process for electronic submissions with a De Novo electronic template. The association’s comment letter raises these concerns for the agency to consider as it develops a final guidance: * ensure the De Novo eSTAR guidance
Drugs
The American Society of Hematology says it commends FDA for releasing its draft guidance on developing products to prevent or treat graft-versus-host disease (GVHD). The society comment letter says investigators and hematologists conducting stem cell transplants can benefit from the guidance on acute and chronic GVHD. “To ensure
Devices
FDA has cleared a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe obstructive sleep apnea (OSA). The clearance was based on “statistically significant data” from 73 severe OSA patients that showed 80% of patients experienced an improvement of