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FDA To Re-Issue Draft Guidance On Investigational Device Exemption Standards

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.

The device center says it plans to re-issue its draft guidance on the investigation device exemption process in response to recently enacted restrictions from Congress.

The draft guidance, originally released in November 2011, is focused primarily on introducing new terms and procedures to help clarify the status of studies that have been cleared to begin...

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