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FDA proposes tightening post-market oversight of medical devices

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e6140 (Published 11 September 2012) Cite this as: BMJ 2012;345:e6140
  1. Bob Roehr
  1. 1Washington, DC

The US Food and Drug Administration is proposing additional steps to strengthen the post-market surveillance of medical devices. The FDA’s recommendations were made public in a report released on 6 September.1

“A medical device postmarket surveillance system should quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices,” says the introduction to the report.

A federal law passed earlier this year required the FDA to include devices under the existing …

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