FDA: Device Trials that Use Leftover, De-Identified Human Specimens Need IRB Review
The FDA has published a letter to industry reminding sponsors that IRBs must review all diagnostic device trials involving human participants, even ones that use leftover, de-identified human specimens.
Specifically, data used to support investigational device exemptions, marketing applications and submissions to the agency, including in vitro diagnostic (IVD) technical or analytical studies that use human specimens, are required to undergo IRB review.
In its letter, the agency cited its 2006 guidance on the subject, which explains that while the agency will use enforcement discretion on requirements for informed consent under certain situations, even those exempted trials still require IRB reviews.
“The FDA issued the guidance to help reduce obstacles for IVD device development and to facilitate development consistent with GCP and clinical trials. However, the guidance expressly states that for those clinical investigations in which we intend to exercise enforcement discretion for informed consent, the requirement for IRB review … remains,” the agency said.
Read the guidance here: https://bit.ly/3vygFz2.
Read FDA’s letter to industry here: https://bit.ly/3B3oY76.