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The nonprofit European Association of Medical Devices Notified Bodies, known as Team NB, has published a form letter for updating devicemakers on the status of their submissions as the EU continues the transition to its new Medical Device Regulations (MDR). Read More
Medical devicemaker Stryker has disclosed that U.S. authorities are conducting an investigation of the company for potential violation of an antibribery law covering overseas business, making this the third such investigation of the Kalamazoo, Mich.-based company in a decade. Read More
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Read More
Congress granted the FDA new authority under the Food and Drug Omnibus Reform Act of 2022 to ban a medical device for one or more intended uses, but it remains to be seen how the agency will use the new enforcement tool, according to Washington, D.C.-based attorney John Claud of the law firm Hyman, Phelps & McNamara. Read More
Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and a draft guidance on decentralized clinical trials for drugs, biological products and devices. Read More
There is no other cleared device that can allow fully paralyzed or locked-in patients to communicate once eye-tracking is no longer possible for the patient, the company said. Read More
Devicemakers and equipment servicing companies are locked in a battle over the idea of “right to repair,” debating whether third-party repair companies should be federally regulated in the same way device original equipment manufacturers (OEM) are. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More