End in sight for US ban on unapproved devices literature
This article was originally published in Clinica
Executive Summary
The US FDA has indicated it may lift its prohibition on manufacturers' dissemination of textbooks and peer-reviewed articles that describe unapproved uses of medical devices. The agency last week announced that it "has determined that distribution [to healthcare professionals] of textbooks that do not highlight unapproved uses should be permitted. Similarly ... the FDA has determined that certain peer-reviewed journal reports upon which FDA relied for approval of a product may be distributed even if they contain information (eg reference to unapproved uses) that is inconsistent with the FDA-approved labelling for the product."
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