How to Comply with the Food and Drug Administration's “Investigational Device Exemption (IDE)“ Regulations Including an Application Form (Revised January 1982) Prepared by the ASAIO Standards Committee,

摘要

ABSTRACTThis is a revision of the IDE Application Form, “How to Comply with the Food and Drug Administration's New ‘Investigational Device Exemption (IDE)’ Regulations, Including an Application Form“ originally published inArtificial Organs, Volume 4, Number 4, November 1980.This publication updates the IDE application form to facilitate compliance with the amended investigational device exemption regulations now in