When FDA Can Accept Greater Premarket Uncertainty for Medical Devices

Submitted by admin on August 30, 2019 - 7:33pm

Source:

RAPS.org

News Tags:

devices

FDA

Headline:

When FDA Can Accept Greater Premarket Uncertainty for Medical Devices

snippet:

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized guidance on Thursday that explains when agency review staff may be able to accept greater premarket uncertainty about a device’s benefit-risk profile.

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When FDA Can Accept Greater Premarket Uncertainty for Medical Devices

When FDA Can Accept Greater Premarket Uncertainty for Medical Devices