FDA MDEpiNet Panel: Device Surveillance Balancing Act

“We want a system that knows enough not to trigger panic when it’s simply the steam of boiling water,…[but] perhaps there should be some alerting when the entire oven is on fire,” said Boston cardiologist Frederic Resnic at the annual gathering of the public-private Medical Device Epidemiology Network.

Improving safety surveillance of devices in the U.S. will require a balancing act: On the one hand, establishing a robust framework for post-market data collection, but on the other hand, ensuring that the framework does not overburden users and trigger public alarm without real cause.

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