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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
“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
As part of its Medical Device Development Tools (MDDT) initiative, the FDA has developed a screening tool to aid in evaluating the biocompatibility of polymeric medical device components that contain color additives. Read More
Percussionaire was handed a Form 483 following an inspection of its Sandpoint, Idaho facility for not reporting a serious medical event and for not properly handling and reporting a firmware issue with some accessory devices. Read More
The FDA issued an update on Baxter Hillrom’s Sept. 30 recall of its WatchCare incontinence management system, declaring it a Class 1 recall because of the risk of serious injury or death. Read More
Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More