UAMS acts as the sponsor for all investigator-initiated Investigational Device Exemptions (IDE) filed on behalf of our investigators (UAMS policy 12.1.11). The following are functions and services of the Regulatory Affairs Unit:
- Regulatory Strategy — assist in planning for the regulatory needs throughout an investigational product’s development lifecycle or a series of investigations.
- Food and Drug Administration Interaction — conduct and coordinate all communication with this government agency including submissions, teleconferences, and meetings.
- Risk Determinations and Project Evaluation — evaluate each device study for the risk determination, regulatory responsibilities and handle questions regarding risk determination or project evaluation that need Food and Drug Administration insight.
- Non-Significant Risk (NSR) Device Investigations — follow the abbreviated federal Investigational Device Exemption regulations for non-significant risk devices, coordinate Food and Drug Administration interactions, maintain sponsor records and inform investigators of their responsibilities.
- Significant Risk (SR) Device Investigations — complete and submit the full Investigational Device Exemption to the Food and Drug Administration for significant risk devices, coordinate Food and Drug Administration 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 the Food and Drug Administration.
- Filing and Maintenance — assist investigators in the preparation, filing, and maintenance of all applicable regulatory documents required for Food and Drug Administration submission.