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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
After months of delay, the FDA and the device industry have reached an agreement in principle on the agency’s commitments for the fifth iteration of the Medical Device User Fee Act (MDUFA) – for fiscal years 2023 to 2027 — but the two sides are still working out details of a commitment letter that was due to Congress by Jan. 15. Read More
In a rare move by the FDA, the agency ordered Philips Respironics to notify patients and other customers of the company’s June 14, 2021, recall of certain models of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive-airway pressure (BiPAP) machines. Read More
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More