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

Article preview from Medtech Insight - July 2013

FDA detailed its proposal for a new “pre-decisional IDE review process” in a revised draft guidance issued June 14.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

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

Article preview from Medtech Insight - July 2013

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. The process would pinpoint not only issues that will lead to IDE rejection but also problems that are likely to limit a firm’s chances of gaining marketing approval after a study is complete.

The process is detailed in a revised draft guidance issued June 14. The document is an update to a 2011 draft guidance on possible FDA decisions that could result from an IDE submission.

The initial draft guidance tweaked the definition of an IDE “approval with conditions” and introduced the concept of staged IDE approvals. Those concepts are generally supported by industry and remain consistent in the new draft. But the FDA Safety and Innovation Act of 2012 required FDA to rework other parts of the 2011 draft guidance.

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