Investigational Device Exemption Submission
UAMS acts as the sponsor for all investigator-initiated IDEs 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.
- FDA 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 FDA insight.
- Non-Significant Risk Device Investigations (NSR) – follow the abbreviated federal IDE regulations for non-significant risk devices, coordinate FDA interactions, maintain sponsor records and inform investigators of their responsibilities.
- Significant Risk Device Investigations (SR) – complete and submit the full Investigational Device Exemption (IDE) to the 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 (510K) or approval (PMA) for a medical device to the FDA.
- Filing and Maintenance – assist investigators in the preparation, filing, and maintenance of all applicable regulatory documents required for FDA submission.