Include IFU in Class II Medical Device Marketing Brochure?

MedicalDevice123

Regulatory affairs specialist
#1
Hi,

We have written a 510(k) for a class 2 medical device and submitted the Instructions for Use and the Brochure. The FDA feedback we receive is:
  • Indications for Use (IFU) are not clearly stated in promotional material for the devices. On page 108 (Brochure), it indicates that “The device does….” which is not consistent with your proposed IFU. Therefore, to properly inform the user of the intended use, please place your proposed IFU at the beginning of your product labeling as a standalone statement in the promotional material.
Does this mean we need to include the complete Instructions for Use in our Marketing materials (as is common in Pharma)? Or only include an identical Indications for Use in both Instructions For Use and the Brochure? Do the contraindications, warnings and precautions need to be part of the marketing materials for FDA?

Thank you very much for your feedback.
 
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Edward Reesor

Trusted Information Resource
#2
From what I read in your post, the entire Instructions for Use (what I consider IFU to represent) don't have to be in the brochure, but only the indications of the device itself (e.g. "for lowering blood pressure") as a stand alone statement. The response from the FDA appears to that the brochure you provided states a different indication that is stated on the 510(k) submission ("for monitoring blood pressure").

I don't believe that other information needs to be on the promotional material, however it might be considered if there is a risk of off-label use or if there is a high risk of critical error causing death.
 

JeantheBigone

Quite Involved in Discussions
#3
There is some confusion I think between IFU and IFU.

The first IFU is "Indications for Use."
The second IFU is "Instructions for Use."

:confused:

I'm used to only using the abbreviation "IFU" to refer to "Instructions for Use" but where I now work I am outnumbered. :cool:

If it were up to me, "IFU" would be reserved for "Instructions for Use" and the term "Indications for Use" used by FDA (but not the rest of the world) would be changed to "Intended Use" to avoid confusion.

Bottom line, put your full Indications for Use on anything that reaches the end user.

I do not think you need the Instructions for Use in all promotional materials,
 
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