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The Food and Drug Administration (FDA) is announcing a public workshop entitled “Spinal Device Premarket Review.” The workshop is intended to enhance public understanding of FDA’s review of data and information submitted to support premarket authorization for spinal devices falling under 21 CFR 888.3070 and 21 CFR 888.3080 by highlighting key sections of a 510(k) submission. The workshop will be webcast only.

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