The final guidance issued on Wednesday establishes new recommendations and considerations for a live or pre-recorded broadcast of a surgical or percutaneous procedure under an investigational device exemption (IDE).
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) provides recommendations with regard to human subject protection measures and what to include in an IDE application for sponsors seeking to conduct these broadcasts, known as live case presentations.
The final guidance nixes some of the context from the April 2014 draft version
related to the uptick in the number of requests for live case presentations within certain clinical investigations that prompted the agency to clarify its expectations. The final guidance clarifies how to evaluate the appropriateness of a live case presentation within an IDE application.
CDRH adds to the draft guidance that “an acceptable live case presentation could include a high-risk procedure in which the risks are well-understood, risk mitigations are in place, subjects are selected with appropriate clinical and anatomic characteristics, and the informed consent process is conducted in accordance with 21 CFR part 50.”
Building on the 2014 draft version, the 12-page final guidance further clarifies how to reduce the risk of prolonging surgical procedures or distracting surgeons and what to include in informed consent forms. In addition to the four criteria the draft version listed, CDRH says informed consent forms should also describe how it’s unknown if participating in live case presentations will affect clinical outcomes and “whether additional follow-up and evaluation may be warranted.”
A new recommendation instructs sponsors to record the surgical or percutaneous procedure to keep the number of live case presentations at a minimum, coinciding with the revised definition of live case presentation in which CDRH clarifies that the procedure can be live or pre-recorded.
The final guidance also follows industry group AdvaMed’s request
that FDA clarify that sometimes sponsors have to submit a live case presentation via an IDE supplement as “in many instances, information about a specific live case presentation will not be known or available at the time the original IDE is submitted.” To this end, the final guidance adds recommendations specific to the use of IDE supplements when seeking live case presentations.
“If it is not anticipated at the time of the original IDE, the live case presentation request should be submitted as a supplement to the original IDE in accordance with 21 CFR 812.35(a) at least 30 days prior to the planned presentation,” CDRH clarifies in the final guidance. “This is because original IDE applications and supplements have a 30-day review period.”
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff