Advertising medical devices in the U.S - Advertising regulations or guidance documents

MariaHj

Registered
Hi everyone,

Can I ask please if there are any advertising regulations or guidance documents for advertising medical devices in the U.S? or for advertising for health care professionals?

Thank you!
 

MsElias

Registered
Just to piggy back here... I am trying to find guidance on whether or not a manufacturer can promote for a specific surgical approach (e.g., minimally invasive) for an implant if the approved labeling makes a general statement to the effect of "techniques for implanting the device are at the discretion of the surgeon correlating to their training ....." I am of the opinion the manufacturer of record would be required to update their design file to include evidence the instruments and implants can be be used as intended through a smaller incision. However, I am struggling with finding clear guidance on this, or a warning letter example to share. I have already reviewed the relevant guidance documents listed in the link Ronen provided above, and the guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling-Questions and Answers uses the same logic I have been using in my reasoning, but it would be great if I could find more concrete examples. Anybody have any suggestions?
 
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