FDA's Role in the Off Label Use of Medical Devices Explained by Dr. Kanal, MD.

Zone 3 Podcast

Watch on YouTube --> FDA's Role in the Off Label Use

In this episode of Zone 3 Podcast, we are lucky to have returning guest Emanuel Kanal, MD, FACR, FISMRM, MRMD, MRSE, AANG. Chief, Division of Emergency Radiology and Teleradiology. Director, Magnetic Resonance Services. Professor of Radiology and Neuroradiology. Department of Radiology University of Pittsburgh Medical Center, here to discuss the FDA's role.
Specifically, how the FDA only governs who can market in the US, not how MD should practice medicine.

He also discusses how off-label use should be the standard if that is what is best for the patient regardless of FDA approval. Dr. Kanal helps to explain this by discussing an example about the neonate formula.

He urges viewers to understand FDA’s approval regarding MRI safety is only to those companies who find it beneficial(profitable) to get FDA approval. He also talks about the FDA approval process and how the safety guidelines are created. He takes us through many dates on how the FDA came to be, reminding us of the big picture of the FDA's role as a federal regulator.

Toward the end, Dr. Kanal discusses his passion for flying. As a licensed pilot, Dr. Kanal tries to find the time in his busy schedule. It was fun to sit down with Dr. Kanal and see and hear that passion when spoke to him about something other than Diagnostic imaging.

Thanks for Joining Us here in Zone 3.

Timestamps below
00:00 intro
00:54 Dr. Kanal Intro
26:47 FDA's Role and Why they don't have oversight over how MD practice Medicine
51:00 -Liability when going off Label
1:20:45 Message to Technologist
1:28:51 Community Questions
1:50:19 Outro with Sponsor popup

About our Sponsor:
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Aegys is committed to providing innovative product and process solutions that enhance overall magnet safety and improve efficiency. TechGate Auto is a Zone 4 Barrier System that keeps patients and MRI technologists safe. TechGate Auto allows technologists to focus on the care of patients and efficient room turnaround rather than worrying about anyone entering the MRI room behind them. Easy to use and designed for the MRI environment, TechGate Auto is deployed whenever the technologist enters or leaves the MR room or via push-button remote control, providing an immediate physical restriction of access to all unauthorized individuals.

The use of a “caution” barrier at the entrance to the MR room is now a recommendation of the American College of Radiology MR Safety Committee.

Links
Aegys' Tech Gate Auto- https://aegysgroup.com/
Questions Link- https://community.imagingqa.com/