FDA releases new case study about the IDE process

The FDA announced the it has published its 8th case study entitled “The Investigational Device Exemption (IDE) Process: When is an IDE the Right Choice?” This new case explains what an IDE study is, what types of medical devices do and don’t require an IDE, and how the IDE approval process works. It is part of the National Medical Device Curriculum, which seeks to provide innovators with FDA-endorsed knowledge on navigating its regulatory processes for medical devices.

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