Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration’s Device Center

On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. While the guidance document is helpful in explaining the appeals processes, it does not go far enough. Even if the draft guidance is finalized, the appeals process at CDRH remains in urgent need of reform.