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Device history records for two of the firm’s Class II medical devices didn’t include or refer to the location of their primary identification labels and labeling for each unit. Read More
The agency learned that patients are sometimes being treated with medications that are not approved for use with an intrathecal implanted pump. Read More
Most IMDRF regions have developed programs for consensus standards, setting the stage for future harmonization, the Standards Working Group said. Read More
Class III and IV medical devices produced using additive manufacturing “require a review of submitted evidence of safety and effectiveness before a license can be issued,” the agency said. Read More
The FDA disagreed with OIG’s conclusions that the lack of a formal arrangement with federal partners hurts information flow about cybersecurity. Read More