sábado, 15 de febrero de 2014

CDRH Industry Update: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff - Guidance for Industry and FDA Staff

The purpose of this guidance is to provide an overview of the mechanisms available to applicants through which they can request feedback from the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications or other premarket submissions, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (de novo petitions), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, and including certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). This guidance provides information regarding the logistics for submission, receipt, tracking, and review of/response to these requests.  To view the guidance, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf

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