Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable." This guidance is intended to inform sponsors, institutional review boards, clinical investigators, and agency staff that under circumstances described in the guidance, that FDA does not intend to object to the use in device investigations, without informed consent, of leftover human specimens that are not individually identifiable. FDA intends to include in this policy leftover specimens that are remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded, specimens obtained from specimen repositories, and specimens that are leftover from specimens previously collected for other unrelated research. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).