Hello! The guidance in question was specifically developed with approved products (drugs or devices) in mind; however, it does touch on unapproved and unapproved uses in a couple of areas (e.g., dissemination of clinical practice guidelines).
When one is examining what kinds of communications might be possible pre-approval, the best guidance is 21 CFR 312.7. While that reference is specific to drug products, it applies equally to devices - it would be a violation of the FD&C Act to promote a medical product prior to approval/clearance. The definition of what "promotion" is can be a very gray area - inclusive of not just marketing materials, but other activities conducted in the pre-approval setting like medical affairs interactions in the field (i.e., presentations to KOLs, scientific booths at medical congresses, etc.). In a booth setting, FDA will view the content and dialogue through a "promotional lense" since its on the exhibit hall floor (traditionally viewed as a promotional space). However, if it is an investigator presenting findings of clinical research in the educational sessions, that is normally acceptable. In that instance, industry has to be careful not to be "orchestrating the message" and implying conclusions of safety and efficacy for the unapproved product. Certainly, presentations by KOLs and investigators independently of a company are scientific exchange and allowed.
Importantly, promotion of unapproved products is something to avoid. Many companies will conduct disease education in the pre-approval setting to help raise awareness of a particular condition. Also, other types of communications (i.e., communications with payors) are allowed in the pre-approval setting so that they can be appropriately planning coverage decisions for future products - but those are special situations and covered by other FDA guidances (see the 2018 FDA Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers).
Hope that helps as a start.
Sincerely,
Glenn Byrd
President, RAPS Board
President, GByrd Ad-Promo Solutions, LLC
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Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
Woodbine MD
United States
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Original Message:
Sent: 08-Jan-2020 11:32
From: Anonymous Member
Subject: Good Reprint scientific publications
This message was posted by a user wishing to remain anonymous
Hi all,
I wonder if the guidance "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices" applies only to new uses of previously cleared/approved devices or can be extended also to completely new devices that haven't been cleared yet, e.g., investigational devices.
Also, what are the allowed promotional activities for investigational devices? is the presentation of scientific clinical research at conferences ok if it is not initiated by the company (i.e., initiated by KOLs, research collaborators, etc.)?
Thanks in advance