This policy provides definitions for significant risk (SR) device and non-significant risk (NSR) device, and discusses major differences between SR and NSR device studies.  The policy explains IRB responsibilities and Investigator/Sponsor responsibilities in making a risk determination for a device study.

The policy describes how the IRB confirms and documents the presence of an IND for research involving the use of drugs or biologics (other than the use of a FDA approved, marketed drug/biologic in the course of medical practice). IND exemption criteria are outlined.

This policy describes how the IRB confirms and documents the presence of an IDE for research conducted to determine the safety or effectiveness of a medical device. IDE exemption categories are presented, as are criteria for an abbreviated IDE.

The policy describes additional responsibilities belonging to DUHS Investigators who carry the dual roles of Investigator and Sponsor.  If an Investigator in a proposed research project is also the IND/IDE holder and/or is otherwise subject to FDA regulations related to duties as a sponsor/investigator, then additional institutional requirements and responsibilities to FDA apply.

The policy defines in vitro diagnostic (IVD) device, and describes FDA Guidance stating FDA will exercise enforcement discretion with respect to its current regulations governing the requirement for informed consent when human specimens, not individually identifiable, are used for FDA regulated in vitro diagnostic device investigations.

This policy provides the procedures around using a humanitarian use device, the investigator's and IRB’s responsibilities, and considerations for reporting.