Regulatory Science Symposium: Clinical Trials with Medical Devices Session 9: Wrap Up (2019)

1. Audience polling
   1. Sponsors that submit a Premarket Approval Application to the FDA are typically required to conduct the following studies:
      Ans: (C) Feasibility and pivotal – Sponsors that submit a Premarket Approval Application to the FDA are required to perform feasibility as well as pivotal trials as these are life-sustaining medical products.
   2. FDA requires that you apply for an Investigational Device Exemption (IDE) for:
      Ans: (C) Significant Risk Devices – An IDE is required for all the Significant Risk Devices by the FDA as that would allow the sponsor to conduct clinical studies on the investigational device in order to collect safety and effectiveness data.
   3. Study documents that should be monitored can include:
      Ans: (E) a, b & c – Study documents that should be monitored include Quality of life question responses, Blood pressure recordings as well as Signed informed consent documents.
   4. Why are clinical trials performed?
      Ans: (E) a, b & c – Some of the reasons why clinical trials are performed – to obtain regulatory approvals, to receive reimbursements from insurance companies and to make marketing claims about the product.
   5. Sponsors of IDEs are exempt from the requirements for design controls. (T/F)
      Ans: (B) False – Sponsors who submit an IDE can be exempt from submitting a PMA or pre-market notification or even Quality System regulations while the device is under investigation. However, they need to submit the design control requirements with the IDE.
2. About USC MESH Academy
3. Monitoring Module and Clinical Research Professional Training
4. Resources
5. Certificate of Completion

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu