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The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to compliance company Stericycle. Read More
The FDA is revising an August final guidance on design considerations for home use devices to reflect growing concerns about power outages and the potential for electromagnetic disturbances. Read More
The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
By the end of next year, the FDA expects to release rules on the regulation of sunlamps, postmarket safety reporting requirements for combination products and international clinical trials, among other priorities. Read More
The British government says it will conduct a massive review of how new medical devices and in vitro diagnostics are developed, with the aim of bringing products to market faster and speeding patient access. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
More devicemakers are choosing the de novo approval pathway to get novel low-risk technologies to market quickly, thanks to changes in the way the FDA reviews these products that took effect two years ago. But knowing how to pitch a petition is key to success, an expert says. Read More
Danaher’s plan to snap up dental implant company Nobel BioCare and Roche’s purchase of InterMune helped drive a strong third quarter for life sciences mergers and acquisitions, a new report from PricewaterhouseCoopers shows. Read More
Devicemakers may need to redesign scores of products and change their sterilization methods if the Environmental Protection agency goes through with plans to classify ethylene oxide as carcinogenic when inhaled by humans. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More