Public can report medical device problems at new FDA webpage

Published 9:36 am Tuesday, October 25, 2016

By Jim Spencer

Minneapolis Star Tribune

WASHINGTON — The U.S. Food and Drug Administration has set up a new webpage where the public can report allegations of regulatory misconduct against medical device makers and marketers.

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Among the examples of things that might be reported through the webpage are charges that manufacturers or marketers improperly promoted non-FDA-approved uses of products or that companies failed to tell the FDA about “device-related safety concerns” as federal regulations require.

In April, the Star Tribune reported that Medtronic was slow to report more than 1,000 injuries and malfunctions related to a company-run study of its Infuse Bone Graft. The adverse events should have been reported individually to the FDA in 2008. Instead, they were summarized in a single medical device report in 2014.

Last week, the Star Tribune reported that the FDA’s retrospective summary reporting program allowed at least two dozen device makers, including Medtronic, to keep from public view overdue details of injuries and malfunctions possibly related to their products.

An FDA spokeswoman said the webpage was not a response to recent news articles. It “was developed to provide the public with more information on allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA.”