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Manufacturers responsible for third-party promotional materials

This article was originally published in Clinica

Executive Summary

Device manufacturers may be held responsible when customers promote unapproved uses of their products, according to the latest action by the FDA in relation to US Surgical's biopsy device. Promotion by manufacturers of unapproved uses can lead to product seizures, injunctions and civil penalties, but medical practitioners have freedom of practice to use approved products for other indications. The FDA is prepared to intrude on this freedom, through the manufacturer, reports Clinica's Washington correspondent, Duffy Miller.





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