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The FDA is considering how to offer more regulatory flexibility for medical device software, said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). Read More
Unimicro Medical Systems has been sent an FDA warning letter for failing to comply with the agency’s Quality System Regulation (QSR) in manufacturing needles used in laparoscopic surgery. Read More
After a long delay, the FDA said it has finally reached an agreement with medical device representatives on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Act (MDUFA). Read More
Two European devicemaker trade groups, one German and the other French, have joined the chorus calling on the European Union to postpone implementing its Medical Device Regulation (MDR), which took effect May 26, 2021, with a three-year transitional period that will end May 26, 2024. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
Among other measures, the association wants the federal government to partner with the device industry for “warm base manufacturing” arrangements. Read More
A jury in a federal court has found Johnson & Johnson subsidiary DePuy Synthes guilty of infringing Utah orthopedic surgeon Gary Rasmussen’s patent for a knee prosthesis innovation and been ordered to pay him $20 million. Read More
The FDA has posted a warning on its website against using Apyx Medical’s Renuvion/J-Plasma device for aesthetic dermatology procedures, which has caused burns and other serious adverse events. Read More
San Francisco, Calif.-based ProSomnus Sleep Technologies said that several postmarket studies of its EVO Sleep and Snore Device have shown it be an effective alternative to continuous positive airway pressure (CPAP) therapy in treating obstructive sleep apnea (OSA). Read More