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Industry Asks FDA To Relay Study Design Concerns Separately From IDE Decisions

In comments on FDA’s draft investigational device exemption guidance, device manufacturers ask the agency to communicate any study design considerations or future considerations for IDE studies in communications separate from the official IDE decision letter.

Device companies told FDA it should outline any study design considerations or future considerations for a sponsor’s investigational device exemption trial in separate communications from the IDE decision letter. The feedback responded to FDA’s June draft guidance on the IDE program.

The draft guidance, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” is a revision of an earlier version issued in...

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