UAMS.EDU

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 the functions and services of the Regulatory Affairs Unit:

  • Regulatory Strategy – assist in planning for the regulatory needs throughout a product’s development lifecycle or a series of investigations.
  • FDA Interaction – conduct and coordinate all communication or correspondence 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.

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