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The FDA has closed out a warning letter sent to Dayton, Ohio-based Innovative Sterilization Technologies (IST) in 2019 for marketing a reusable sterilization container for uses the agency had not cleared, the company said.
The company seeks to replace pulse oximeters to measure oxygen levels of sepsis, trauma, and cardiac surgery patients who are “on the verge of organ failure.”
An independent committee of the UK’s National Institute for Health and Care Excellence (NICE) has proposed that England’s National Health System (NHS) use hybrid closed-loop systems for managing difficult to control blood glucose levels in type 1 diabetics.
The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”
The Center for Devices and Radiological Health (CDRH) issued 39 final guidances in 2022, nearly doubling the 21 issued the previous year, but it was a Feb. 23 draft rule that garnered the most attention — Medical Devices; Quality System Regulation Amendments — that proposes to align the 20-year-old FDA quality system requirements (QSR) with International Organization for Standardization (ISO) requirements.
With user fee legislation now firmly in place, a new Congress ready to begin legislating in 2023, and an omnibus package signed into law funding the FDA for another year, we talked with Steven Grossman, executive director of the Alliance for a Stronger FDA, about the big issues that face the agency as we head into the new year.
Medical device distributor Jet Medical has agreed to pay $200,000 in criminal penalties to settle allegations that it misbranded its Allevio SPG nerve block catheter as a migraine device.
Devicemakers can request an exemption to submit adverse event data from real-world data (RWD) sources in formats other than the FDA’s electronic reporting format, the agency said in an update of its web page on medical device report (MDR) exception requests.