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

FDA detailed its proposal for a new “pre-decisional IDE review process” in a revised draft guidance issued June 14.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.

FDA is proposing a new voluntary, interactive review process to help companies maximize their chances of gaining investigational device exemption approval for a study that also has a good chance of supporting marketing clearance or approval.

The “pre-decisional IDE review process” would allow device makers to submit full protocols and data to FDA and receive detailed feedback on possible insufficiencies before formally filing for an IDE....

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