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Patient groups and FDA advisory panel members sparred over whether a controversial treatment for uterine fibroids should be removed from the market, with the former claiming that power morcellators pose a serious health risk and some panelists saying the risks have been overstated. Read More
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. Read More
A group of Senate Democrats is pressing the Office of Management and Budget to release long-promised draft guidance on laboratory-developed diagnostic tests. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a new report from the Government Accountability Office. Read More
Australia’s Therapeutic Goods Administration logged a total of 3,309 adverse event reports in 2013, the overwhelming majority from manufacturers, according to a new report. Read More
Emailing recall notices to clients may seem efficient, but it could cause a host of concerns around confidentiality and effectiveness, a CDRH official warns. Read More
South Africa is taking another stab at regulating medical devices and in vitro diagnostic products, this time via a regulation that would bring them under the purview of the Medicines Control Council. Read More