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The European Medicines Agency is seeking information on an implant sold by a Medtronic unit after inspectors determined that a U.S.-based supplier of an active substance for the product had deviated from good manufacturing practices. Read More
A California doctor could serve up to 20 years in prison for treating patients with an unapproved intrauterine device that he purchased over the Internet. Read More
As the FDA continues negotiations with industry on reauthorization of the Medical Device User Fee Amendments for 2018 to 2022, stakeholders have offered recommendations for improving the program. Read More
FDA officials often attend tradeshows to check out the latest in medical technology. But did you know they’re also listening for violative discussions of unapproved and uncleared products? Read More
With an eye toward providing safe, effective medical devices to patients, Germany’s Federal Institute for Drugs and Medical Devices is looking ahead to the challenges and opportunities that could present themselves over the next decade. Read More
A new Government Accountability Office report has found that most companies don’t know the origin of their so-called conflict minerals — tantalum, tin, tungsten and gold — meaning they could be acquiring them from countries rife with humanitarian abuses. Read More
A consumer advocacy group is calling on the FDA to retract draft guidance on patient preference information and end its relationship with a consortium that it maintains is dominated by medical device manufacturers. Read More