April 2016

It is the policy of the Organization that human subjects research studies of medical devices must be reviewed and approved by an IRB before the research may begin.  Except where device studies are exempt from Investigational Device Exemption (IDE) requirements under 21 CFR 812.2(c), the JHM IRBs will determine at a convened meeting whether the device as used in the research represents a non-significant risk (NSR) or a significant risk (SR) to the research subjects (see 21 CFR 812.3(m)).  The IRB will document this determination in the minutes.  Proposals involving a device determined to represent a SR may not proceed without submission of an Investigational Device Exemption (IDE) application to the FDA and subsequent receipt of confirmation of the FDA decision on the application. 

Researchers who serve as a sponsor/investigator for an IDE research project are required by the Organization to follow FDA regulations 21 CFR 812 Subpart C applicable to sponsor responsibilities.  Device accountability is the direct responsibility of the IDE sponsor/investigator.  Compliance Monitoring Specialists of the OHSR will perform a site visit of an investigator holding an IDE to assess compliance with FDA sponsor requirements in 21 CFR 812 before initiation of the research, and recommend corrective actions where appropriate.  The monitors will conduct a follow-up routine monitoring visit one year after the pre-enrollment visit.  Subsequent monitoring visits may be performed, if necessary.