FDA Proposes Program to Offer Feedback Earlier, Process IDE Applications Quickly

A voluntary program proposed by the Food and Drug Administration June 14 is designed to expedite approval for a clean, unconditional investigational device exemption (IDE) application using more feedback to applicants before their first official IDE submission.

“Pre-Decisional IDE Process” is part of a draft guidance, FDA Decisions for Investigational Device Exemption Clinical Investigations, that FDA reissued to comply with a provision in the FDA Safety and Innovation Act (FDASIA) (Pub. L. No. 112-144) on certain situations in which FDA cannot disapprove an IDE. The original draft guidance, FDA Decisions for Investigational Device Exemption (IDE) Clinical ...