Tag Archives: guidance document

FDA Finalizes CDRH Appeals Process Guidance, Issues Draft Guidance on Section 517A

On May 17, 2013, FDA took significant steps to update its appeals process for medical devices.  First, FDA finalized its guidance on CDRH Appeals Processes, which “describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.”  Second, FDA issued a new draft guidance on Questions and Answers … Continue Reading