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Sponsors of devices already cleared through the FDA’s 510(k) pathway that wish to gain approval for changing the sterilization method they use may find it easier to do so under a new pilot program the agency is considering. Read More
Dental Technologies of Lincolnwood, Ill., drew an FDA warning letter for not adequately investigating a manufacturing problem, among other quality violations. Read More
Sponsors of device trials in the EU that need to make significant changes to their study protocols can consult a new guidance document just released by the European Commission’s Medical Devices Coordination Group (MDCG) — written to support procedures for device trials as they relate to the EU’s Medical Device Regulation. Read More
DeVilbiss Healthcare failed to report a complaint of an injury to a patient using its DeVilbiss 525DS oxygen concentrator to the FDA within the required 30 days, the agency said in a warning letter to the company. Read More
The FDA would gain new authority to compel device manufacturers to comply with record requests under a bipartisan bill introduced in the Senate Tuesday by Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wis.). Read More
The Health Industry Distributors Association (HIDA) is calling for a “fast-pass” system to expedite movement of medical supplies, including personal protective equipment, through the U.S. transportation system. Read More
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The FDA’s draft guidance on investigator safety responsibilities in device and drug clinical trials discusses reporting unanticipated adverse device effects (UADEs) for investigational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