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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
The Department of Commerce has published its long-awaited compilation of all known conflict mineral processing facilities worldwide. But the department admits it lacks the ability to identify which facilities use minerals that finance conflict. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More