Device Innovation: Report Paints Dire Picture; Prez, FDA Take "Positive" Steps
This article was originally published in The Gray Sheet
Last week started off with a particularly negative appraisal for the prospects of continued U.S. leadership in medical device innovation under current policies, but it was followed by two developments that almost appeared as corrective responses by the federal government.
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Regulatory updates from FDA and the White House.
The agency decided not to widely disseminate a report examining 12 high-risk devices that were approved in Europe, but were later found to be dangerous or ineffective.
State of The Union address references “faulty medical devices” with financial fraud and toxic dumping as things in need of smart regulation. The policy significance, if any, is unknown, but the subtext appears to be a subtle shift from mentions of the industry by the president in 2011.