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Guidance Issuing OfficeCenter for Devices and Radiological Health
The purpose of this document is to provide Institutional Review Boards (IRBs), industry, clinical investigators, and Food and Drug Administration (FDA) staff factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation. Applications and supplements that include a live case presentation are referred to generally as “requests” throughout this document.
A live case presentation is a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator (or a discussant other than the operator), with or without expert panel and/or audience interaction. These presentations are typically broadcast at scientific meetings to increase awareness of the clinical investigation and recruit prospective investigators and study subjects. Video recordings or broadcasts that are outside the scope of this guidance include devices or procedures that automatically capture video during use (e.g., laparoscopic and thorascopic devices), telemedicine, and recordings that are routinely captured and broadcast as part of an institution’s standard policies. Investigators should follow the institution’s policies regarding the ability to share these kinds of video recordings in a manner consistent with applicable laws and regulations.
Our expectation is that 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, though exceptions may exist.
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, 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. A live case presentation may not be appropriate for novel devices for which the risk profile is unknown or only limited information is available. On the other hand, an acceptable live case presentation could include a high-risk procedure in which the risks are well-understood, risk mitigations are in place (e.g., 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), subjects are selected with appropriate clinical and anatomic characteristics (e.g., 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 21 CFR part 50.
Investigations involving a significant risk device, including those investigations involving live case presentations, require prior approval by FDA and an IRB (21 CFR 812.20(a)(2) and 21 CFR 812.62). Investigations involving a non-significant risk device, including those investigations involving live case presentations, must be approved by an IRB, but non-significant risk device investigations generally do not require the submission of an IDE application to FDA (21 CFR 812.2(b)(1)(ii)).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-0331.