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The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers. Read More
Belgium-based Euromi has been hit with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including cases of cannula tips from a liposuction system breaking and lodging in patients. Read More
Device makers are paying close attention to a federal court’s ruling that Amarin can use off-label promotion of its cholesterol-lowering drug Vascepa, as long as the communication is truthful and not misleading, two experts say. Read More
The FDA hit Baxter’s Synovis unit with a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
For years, medical device companies have complained of their frustration with inconsistency in decisions by different FDA reviewers. A new program is aiming to change that — at least for startups. Read More
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