How to comply with the Food and Drug Administration's "Investigational Device Exemption (IDE)" regulations including an application form (revised January 1982).
This 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 in Artificial 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 effect.
D001187:Artificial Organs / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D007883:Legislation, Medical; D014481:United States; D014486:United States Food and Drug Administration