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The FDA is asking a federal court to permanently enjoin Pharmaceutical Innovations from manufacturing, selling and distributing ultrasound devices and gels. Read More
CDRH staff recruitment and retention continue to suffer from lack of resources, according to FDA Commissioner Margaret Hamburg, who said she is “stunned” that the agency accomplishes as much as it does. Read More
Former Secretary of State Hillary Rodham Clinton said Wednesday that she would consider repealing the controversial 2.3 percent medical device excise tax. Read More
The FDA Tuesday unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015.
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South Korea’s Ministry of Food and Drug Safety is amending its standards for electromagnetic safety of medical devices to align them with international standards. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
The Centers for Medicare & Medicaid Services’ launched its Open Payments database on Wednesday with no apparent technical problems, but industry concerns over the presentation of devicemaker payments to physicians and how the public will use the data were running high. Read More
The FDA on Thursday launched a new data dashboard, providing a more user-friendly way for manufacturers to obtain inspection and recall data. Read More
The FDA’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
The FDA took another step toward assuming responsibility for the regulation of laboratory-developed tests with Friday’s publication of separate draft guidances on a proposed regulatory framework and medical device reporting requirements. Read More