Enforcement Discretion for Certain IVD Studies

FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. The requirement is articulated in a 2006 guidance document, but FDA now believes it is “possible in certain circumstances for IVD device investigations to be conducted using leftover specimens, which are remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded, that were obtained without informed consent while still protecting the human subjects who are the source of such specimens.”

The agency has clarified that its enforcement discretion does not apply to other good clinical practice (GCP) requirements, including IRB requirements under 21 CFR part 56. “GCP includes review and approval by an IRB before initiating an investigation and continuing IRB review of ongoing investigations,” an FDA notice says.