Greetings all!
I've got a regulatory issue that I've never encountered...
Someone we've contracted with submitted an abstract for publication in a high impact journal without our knowledge. Within the abstract our device is misrepresented, specifically, the regulatory approval, intended/indications for use and metrics are not in line with our current labeling or FDA registration.
Has anyone encountered this type of misbranding and, if so, how was it rectified?
I propose to have the abstract rescinded. If this isn't possible, as it was already published, write to the journal regarding the errors and have them publish a comment. Additionally, I would engage the FDA and discuss the issue with them. Inform the FDA we're aware of the misbranding, state that it was a publication without our knowledge, and propose our solution.
Any additional guidance or thoughts would be most helpful and appreciated.
Regards, TEB
I've got a regulatory issue that I've never encountered...
Someone we've contracted with submitted an abstract for publication in a high impact journal without our knowledge. Within the abstract our device is misrepresented, specifically, the regulatory approval, intended/indications for use and metrics are not in line with our current labeling or FDA registration.
Has anyone encountered this type of misbranding and, if so, how was it rectified?
I propose to have the abstract rescinded. If this isn't possible, as it was already published, write to the journal regarding the errors and have them publish a comment. Additionally, I would engage the FDA and discuss the issue with them. Inform the FDA we're aware of the misbranding, state that it was a publication without our knowledge, and propose our solution.
Any additional guidance or thoughts would be most helpful and appreciated.
Regards, TEB