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# Live Case Presentations in Device Trials Guide
- URL: https://www.fdaweb.com/live-case-presentations-in-device-trials-guide/
- Published: 2019-07-10T12:00:00.000Z
- Updated: 2026-09-15T01:37:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144495

FDA has posted a final guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” The [document](https://www.fda.gov/media/88454/download?ref=fdaweb.com) is intended to provide factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an IDE. It provides information about a live case presentation that should be provided as part of an original IDE or a supplement when requesting inclusion of a live case presentation during a clinical investigation.

FDA says that a live case presentation is a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator, with or without expert panel 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,” it says. “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.”

The agency says it expect 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.” It adds that it may not be appropriate to request a live case presentation for a clinical investigation nearing completion.