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BioWorld - Sunday, May 24, 2026
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Home » FDA updates device safety plan as ICIJ publishes string of negative reports on med-tech industry
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FDA updates device safety plan as ICIJ publishes string of negative reports on med-tech industry

Nov. 27, 2018
By Mark McCarty
Device makers are receiving some interesting signals about the regulation and reputations of their offerings from the FDA and from another group in the last week of November. The FDA has published another update to its medical device safety action plan that includes a proposal to publicly disclose a list of 510(k) devices that cite predicates that were 10 years old at the time. The FDA announcement arrives one day after the International Consortium of Investigative Journalists (ICIJ) released several reports on device recalls, including one report about Medtronic, titled "Medtech Giant Pushes Boundaries As Casualties Mount And Sales Soar."
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