FDA To Re-Issue Draft Guidance On Investigational Device Exemption Standards
This article was originally published in The Gray Sheet
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.
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.
FDA detailed its proposal for a new “pre-decisional IDE review process” in a revised draft guidance issued June 14. The voluntary process would occur prior to IDE submission and would offer companies comprehensive feedback on where their study plans fall short in gaining IDE approval and in ultimately gaining marketing approval.