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The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available. Read More
Speakers at a Food and Drug Law Institute virtual meeting on digital health technology last week agreed that a coordinated vulnerability disclosure (CVD) process is needed to address cybersecurity threats to medical devices. Read More
B. Braun Medical’s Space Infusion Pump System wireless devices have earned Underwriter Laboratory (UL) 2900-2-1 Cybersecurity Assurance Program (CAP) certification, a standard supported by the FDA. Read More
“Individuals need to understand how their data is being collected … and managed and how they can delete their data,” said Jonelle Sauders, associate product counsel for Google Health. Read More
Devicemakers are having difficulty making sense of a recent FDA final guidance targeting clinical decision support software (CDS) for machine learning (ML) products, according to remarks made during a virtual panel held Thursday by the Food and Drug Law Institute (FDLI). Read More
As demand for wearable medical devices that track health measures continues to rise, manufacturers will have to navigate the very real concerns of data privacy as well as more closely define whether a device is clinical or consumer-facing, according to panel members speaking Thursday at a Food and Drug Law Institute webinar, Current Developments in Digital Health Technology and Regulation. Read More
The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More