UTMB as the sponsor of a Significant Risk (SR) device study is required to submit an Investigational Device Exemption (IDE) application under the 21 CFR 812 regulations. The IDE allows the investigational device to be used in a clinical study to collect the safety and effectiveness data required to support a marketing application or a marketed device for a different intended use.
Research clinical Investigations covered under the IDE regulation are subject to varying levels of regulatory policies, regulations and rules depending upon the level of risk. Requirements for an IDE distinguishes between significant and nonsignificant risk device studies and the procedures for obtaining approval to begin the study differ accordingly.
UTMB expects the Principal Investigator (PI) to make the initial risk determination for the proposed Investigational device study and present it to the Research Integrity and Regulatory Affairs Administrator who serves as the "Sponsor" acting for, and on behalf of UTMB. UTMB must submit an "Application for an Investigational Device Exemption" (IDE), together with accompanying materials in electronic format per FDA requirements.
The Office of Research Integrity and Regulatory Affairs represents UTMB as the sponsor administrator. We can help during the study planning and protocol development phases to ensure efficient review. We also provide consultations for study, monitoring, and participant documentation best practices to assure compliance with UTMB, GCP and federal standards.
- submits the application to FDA
- manages compliance with IDE application requirements
- ensures proper monitoring of the investigation and IRB approval
- oversees registration on Clinical trial.gov
Guidance on distinguishing between significant risk and nonsignificant risks studies are outlined in the FDA document 'Significant Risk (SR) and Nonsignificant Risk (NSR) Medical Device Studies'. Every effort will be made to collaborate with the PI, Clinical Research, IRB, and other project team members in the risk determination as needed. Studies of devices that pose a significant risk require both FDA and an IRB approval prior to initiation of a clinical study.
An IDE application is not required to be submitted to, or approved by, FDA for a NSR study. A NSR study is, however, subject to the abbreviated requirements described in § 812.2(b) of the IDE regulations. A NSR device study requires only IRB approval prior to initiation of a clinical study.
An IDE application for a Significant Risk device is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs UTMB via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. UTMB serves as the primary contact for any correspondence or reports from the FDA.