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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,
Author(s) -
Morton William A.,
Dobelle William H.,
Lysaght Michael J.,
Serkes Kenneth,
Siemsen Arnold,
Villarroel Fernando
Publication year - 1982
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1982.tb04069.x
Subject(s) - investigational device exemption , food and drug administration , investigational drugs , business , medicine , clinical trial , risk analysis (engineering) , pathology
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.