We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT).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
The FDA’s Breakthrough Device program, launched in 2018 to meet two agency aims — encouraging innovative devices in areas of greatest need and bringing them to market more quickly — has so far achieved only one. The “fast track” to patient availability has not materialized, regulatory experts say. Read More
The UK plans to extend its acceptance of CE-marked devices through at least 2028, pushing back the current June 30 deadline for devices to comply with the UK’s post-Brexit equivalent. Read More
The FDA has warned users of a vulnerability in Illumina’s genetic sequencing devices that could allow an authorized user to make changes to data from the devices. Read More
To help device manufacturers avoid the most common reasons for delays in technical documentation reviews — incomplete submissions and a lack of cohesive structure — the nonprofit European Association of Medical Devices Notified Bodies (dubbed Team NB) has published a compilation of guidance from many notified bodies in a set of best practices. Read More