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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
Baxter has acquired medical technology company Hillrom in a $10.5 billion deal that will integrate Baxter’s medical and surgical devices with Hillrom’s digital healthcare products, which focus largely on hospital care. 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
Once a company has calculated a sample size for validation and verification testing, it must turn its attention to the process of collecting the samples, which the FDA also will scrutinize. Actual sample collection is “the hard part of the process,” according to Steven Walfish, president of Statistical Outsourcing Services. “How do I know that I can take seven devices and do four replicates each, or if I can do four devices and do seven replicates each?” 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