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Device trade groups have urged the FDA to take its time in implementing a plan to reclassify certain imaging agents as devices rather than drugs. Read More
The FDA has denied a petition from Stryker Medical seeking an exemption from premarket notification requirements for its powered portable stair-climbing chairs. Read More
The FDA is considering how to regulate 3D printed medical devices manufactured at the point of care and is seeking public feedback on a new discussion paper. Read More
BrainsGate’s premarket application for its ischemic stroke treatment device should not be approved by the FDA because it has not been proven effective, an expert panel of the FDA’s Medical Devices Advisory Committee said. Read More
The FDA’s draft guidance on investigator safety responsibilities in device and drug clinical trials discusses reporting unanticipated adverse device effects (UADEs) for investigational devices during a premarket study conducted under an investigational device exemption (IDE), but the agency should clarify if that also “applies to retrospective postmarket studies or real-world evidence (RWE) investigations,” Advanced Medical Technology Association (AdvaMed) said in a written comment to the agency. Read More
The regulatory history of the Penumbra Jet 7 Reperfusion Catheter highlights serious problems with the FDA’s 510(k) clearance pathway, says Kushal Kadakia of Harvard Medical School and co-authors of an article in JAMA Internal Medicine. Read More
Members of Congress from both parties have asked the Centers for Medicare and Medicaid Services (CMS) to take action to deal with “preventable error” leading to false-positive results from blood tests used in the diagnosis of sepsis. Read More
The FDA’s proposed rule on over-the-counter (OTC) hearing aids does not introduce a new device classification, but is more “like a rule of the road,” explained Ian Ostermiller, policy adviser in the FDA’s Office of Policy, during a Tuesday webinar hosted by the agency. Read More
Louisville, Ky.-based devicemaker Induction Therapies has been marketing a microneedling product without FDA approval, the agency said in a warning letter to the company. Read More
Device manufacturing facility workers are routinely exposed to biohazards when they reprocess devices for reuse, even when they are wearing personal protective equipment, researchers have found. Read More
Device industry groups are hesitant to fully endorse the FDA’s push for greater transparency by manufacturers in the labeling information they provide to users of their artificial intelligence- or machine learning-enabled devices. Read More
Roche has acquired Germany-based TIB Molbiol, a long-time partner on diagnostic products, and the company has just released three new tests that can differentiate mutations in the Omicron variant of the SARS-CoV-2 virus. Read More