Regulatory Open Forum

I'm trying to find guidance from FDA over video instructions, marketing, etc for medical devices. My understanding thus far is that creating a video IFU for patient use is labeling and would need to be approved by the FDA. Is this incorrect? Thank you 

Hello Anon

Not all device labeling is submitted for approvals, but yes, advertising and instruction videos are "labeling". Some FDA guidance documents that may help:

Guidance on Medical Device Patient Labeling  (https://www.fda.gov/media/71030/download)

Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers  (https://www.fda.gov/media/102575/download)

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Nov-2023 11:17
From: Anonymous Member
Subject: Video IFU

This message was posted by a user wishing to remain anonymous

I'm trying to find guidance from FDA over video instructions, marketing, etc for medical devices. My understanding thus far is that creating a video IFU for patient use is labeling and would need to be approved by the FDA. Is this incorrect? Thank you 

I'm trying to find guidance from FDA over video instructions, marketing, etc for medical devices. My understanding thus far is that creating a video IFU for patient use is labeling and would need to be approved by the FDA. Is this incorrect? Thank you 

You definitely want to treat it as labeling and follow a process to ensure it is reviewed prior to launch/release. 

You could have a transcribed script to have as something to submit that can demonstrate review history.

If there are images / text on screen that are not in the transcription, I would consider screen shots/slides/stills as well to include in this review package.

Original Message:
Sent: 07-Nov-2023 11:17
From: Anonymous Member
Subject: Video IFU

This message was posted by a user wishing to remain anonymous

I'm trying to find guidance from FDA over video instructions, marketing, etc for medical devices. My understanding thus far is that creating a video IFU for patient use is labeling and would need to be approved by the FDA. Is this incorrect? Thank you