May 2005

It is the policy of the Organization that research involving medical devices must be reviewed and approved by an IRB before the research may begin.  The IRBs will determine whether the research represents non-significant risk device research or significant risk device research.  The IRB will record the rationale for a NSR assessment on the review sheet for determinations made at an expedited review session.  The IRB will document the NSR determination in the minutes for convened discussions.  Proposals that are determined to represent significant risk device research 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. 

The Organization requires a monitoring process for receipt, dispensing, and record keeping concerning devices that are studied using an IDE granted by FDA.  The monitoring process shall be performed by the Compliance Monitoring Specialists of the OHSR.

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.  Compliance Monitoring Specialists of the OHSR must site visit investigators holding an IDE to determine compliance with FDA sponsor requirements in 21 CFR 812 before initiation of the research.  Once an investigator has demonstrated compliance through the monitoring mechanism, additional inspections may not be required for subsequent research involving the investigator held IDE,  The monitors will conduct a yearly review of the specific research protocol as long as IRB approval remains in effect.