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FDA To Re-Issue Draft Guidance On Investigational Device Exemption Standards

This article was originally published in The Gray Sheet

Executive Summary

The device center is responding to a provision in the FDA Safety and Innovation Act, passed last summer, which explicitly prohibits FDA from disapproving an IDE solely because the agency does not believe the study could support approval or clearance.

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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.

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The Pre-Decisional IDE: FDA’s New Proposal To Help Studies Get Started Right

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