FDA Abandons Proposal For Interactive, “Pre-Decisional” IDE

18 Aug 2014

The agency finalized a guidance document on investigational device exemption review decisions, dropping a proposal to establish a new, interactive “pre-decisional” IDE process. Industry had been skeptical that the proposed program would improve efficiency of study reviews, and worries that it would require a lot of FDA resources.

FDA has dropped current plans for establishing a specialized interactive review process for investigational device exemption submissions.

The agency posted a final guidance on FDA decisions for IDE submissions Aug. 18, following up on a...