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FDA Articulates Design Principles For Pivotal Trials In Final Guidance

The agency prefers device pivotal trials to be randomized, double-blinded and controlled, but understands that this is “neither feasible nor practical” for some devices, according to a Nov. 7 final guidance.

FDA retains its preference for device pivotal trials that are randomized, double-blinded and controlled in a recent final guidance, but clearly states that “there are devices for which this design is neither feasible nor practical.”

While this notion was touched on in the 2011 draft guidance, the more prominent acknowledgement in the final document is...

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