New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the design and implementation of adaptive designs in medical device clinical studies used to support Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions, Humanitarian Device Exemption (HDE) applications, and Investigational Device Exemption (IDE) submissions.

Read more: New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies


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