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The EU Commission’s latest guidance on its new medical device regulations provides a detailed explanation of the required content, as well as the structure, for the summary of a report on the results of a clinical investigation. Read More
Netherlands-based devicemaker Philips has agreed to pay $62 million to settle charges made by the U.S. Securities and Exchange Commission (SEC) that it “engaged in improper conduct to influence foreign officials ... to increase the likelihood that Philips’ products were selected” as well as using improper bidding practices in China between 2014 and 2019. Read More
The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs. Read More
Use of ethylene oxide (EtO) for medical device sterilization is safe for employees, neighbors and communities, and is the only viable method for many of the 20 billion devices it sterilizes each year, according to testimony given last week at the Environmental Protection Agency (EPA) public hearing on its proposal to reduce EtO from commercial sterilization facilities. Read More
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
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
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