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CDRH Applies “Grand Rounds” Approach To Risk-Benefit Balancing

Device center staffers met to discuss several pending applications and the factors that should weigh heaviest in their review.

FDA’s device center is taking a page out of the medical education playbook to help ensure that its new paradigm for making risk-benefit decisions truly sinks in with its employees.

CDRH convened the first in a series of planned “grand rounds” sessions earlier this month where dozens of staffers from throughout the center met to discuss several pending applications and...

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