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Medical Devices / Regulatory Affairs

FDA Offers Advice on Benefit-Risk Considerations for Device Submissions

Sept. 9, 2019

The FDA outlined in two new guidances how to assess the risks and benefits of medical devices for premarket submissions as well as for de novo classifications and humanitarian device exemptions.

The level of uncertainty regarding the benefits and risks of a device depends primarily on the type of premarket decision and the context. “The appropriate uncertainty…would depend on the circumstances, including the totality of information about the device,” the agency says, in a guidance on how to deal with uncertainty.

“The continuous, robust generation of evidence throughout the premarket and postmarket setting … is important to continuously refine our understanding of how medical devices are used and perform,” the agency said.

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