DEVICE LABELING GUIDANCE DELAY TO GIVE FIRMS TIME TO MEET EU DIRECTIVE SOUGHT BY OSMA; HIMA, MEDTRONIC, USSC ALSO TO PRESENT AT SEPT. 5 WORKSHOP
This article was originally published in The Gray Sheet
Executive Summary
Implementation of a guidance to standardize device labeling format should be delayed by two to three years, the Orthopedic Surgical Manufacturers Association maintains. OSMA says companies need the time because they are in the midst of revising product labeling to bring it into compliance with the European Union's medical device directive, which becomes mandatory in June 1998.
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