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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
The FDA has released a cybersecurity action plan that aims to incrementally take the agency to a “zero trust” environment meant to strengthen the FDA’s ability to protect sensitive information and decrease overall security risks to the agency. Read More
A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More