For all Investigator-Initiated Trials (IITs) requiring an Investigational Device Exemption (IDE), Office of Research Regulatory Affairs (ORRA) acts as sponsor on behalf of UAMS. The following are the functions and services of the ORRA Regulatory Unit:
- Regulatory Strategy — assist in helping investigators with all regulatory needs throughout the lifecycle of an investigation.
- United States Food and Drug Administration (FDA) Interaction — conduct and coordinate all communication or correspondence with FDA including submissions, teleconferences, and meetings.
- Risk Determinations and Project Evaluation — evaluate each device study to determine risk and level of required regulatory involvement and manage inquiries regarding risk determination or project evaluation that need FDA insight.
- Non-Significant Risk (NSR) Device Investigations — follow the abbreviated federal IDE regulations for non-significant risk devices, coordinate FDA interactions (if necessary), maintain sponsor records and inform investigators of their responsibilities.
- Significant Risk (SR) Device Investigations — complete and submit full IDE package to FDA for significant risk devices, coordinate FDA interactions, maintain sponsor records and inform investigators of their responsibilities.
- Premarket Notification (510K) or Premarket Application (PMA) — coordinate any submission for clearance (Premarket Notification) or approval (Premarket Application) for a medical device to FDA.
- Filing and Maintenance — assist investigators in the preparation, filing, and maintenance of all applicable regulatory documents required for FDA submission.