US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.

Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.