FDAnews Device Daily Bulletin

FDA ISSUES GUIDANCE ON INFORMED CONSENT FOR LEFTOVER HUMAN SPECIMENS USED IN DIAGNOSTIC DEVICE STUDIES

April 25, 2006
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The FDA April 25 issued its "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable."

The agency is issuing the guidance to inform sponsors, institutional review boards, clinical investigators and agency staff that the FDA "intends to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA-regulated in vitro diagnostic device investigations."

The agency noted that it "does not intend to object to the use, without informed consent, of leftover human specimens in investigations that meet the criteria for exemption from the Investigational Device Exemptions regulation at 21 CFR 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not individually identifiable."

The guidance can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0150-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0150-gdl0001.pdf).