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CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Read More
Philips Respironics reports risk assessments of its continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep apnea therapy devices showed that degraded sound abatement foam on the devices would likely not cause “appreciable harm” to patient health. Read More
Among devices subject to an FDA Class I recall from 2018-2022, only one-quarter of recall notices included adequate information to accurately identify the device or component at fault, according to a new study. Read More
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