July 10, 2019
CDRH Issues Guidance for Live Case Presentations During IDE Clinical Trials
July 11, 2019—The FDA Center for Devices and Radiological Health (CDRH) has issued a guidance document on live case presentations during investigational device exemption (IDE) clinical trials. The purpose of this document, which is available online here, is to provide factors for institutional review boards (IRBs), industry, clinical investigators, and FDA staff to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an IDE application.
According to CDRH, this document provides guidance on important information about live case presentations that should be provided as part of original IDE applications or supplements to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.
The CDRH stated that it expects very few investigations under an IDE will include live case presentations. However, by increasing awareness of the study for health care professionals and eligible subjects, live case presentations may lead to new therapies being made available sooner. Because live case presentations are often intended to recruit investigators and subjects, it is generally not appropriate to request a live case presentation for a clinical investigation nearing completion, although exceptions may exist.
Additionally, the agency noted that not all clinical investigations are appropriate for live case presentations. For example, certain high-risk procedures that may adversely impact the subject or certain investigations involving children may not be suitable for live case presentations.
When reviewing an IDE application, the FDA intends to evaluate whether the requested live case presentation raises the risk profile of participation for subjects, such that conducting the live case presentation is not justified. The CDRH noted:
- A live case presentation may not be appropriate for novel devices for which the risk profile is unknown or only limited information is available.
- An acceptable live case presentation could include a high-risk procedure in which the risks are well understood, risk mitigations are in place (eg, the case is being performed by a team of operators with high levels of expertise at a site with an excellent record of both performing the procedure and performing live case presentations), patients are selected with appropriate clinical and anatomic characteristics (eg, a subject that does not have complex anatomy or is not at the highest risk for injury should a complication occur), and the informed consent process is conducted in accordance with law.
- Investigations involving a significant-risk device, including those investigations involving live case presentations, require previous approval by FDA and an IRB.
- Investigations involving a nonsignificant-risk device, including those investigations involving live case presentations, must be approved by an IRB, but nonsignificant-risk device investigations generally do not require the submission of an IDE application to FDA.