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

#1
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!
 
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#4
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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