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Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from IVDs and LDTs, developing SOPs and pharmaceutical quality risk management. 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
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. 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
Over the past week, the FDA issued several documents, including a final guidance for testing drug components for diethylene glycol and ethylene glycol and the announcement of a discussion paper on AI. Read More