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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
Users were advised to remove the affected ventilators from service and quarantine them pending a replacement of the printed circuit board assembly by the company. 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The FDA’s draft guidance on investigator safety responsibilities in device and drug clinical trials discusses reporting unanticipated adverse device effects (UADEs) for investigational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