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HIMA workshop

This article was originally published in The Gray Sheet

Executive Summary

Topics for discussion at the eighth annual Health Industry Manufacturers Association device submissions workshop June 27-29 include FDA's allocation of resources for implementation of the FDA Modernization Act, 510(k) and premarket approval application reengineering initiatives, advertising and promotion, labeling and expedited review. Device center staffers scheduled to speak include: Susan Alpert, director of FDA's Office of Device Evaluation, Phil Phillips, ODE deputy director, and Byron Tart, director, promotion and advertising policy staff. The conference is being held at the Omni Shoreham hotel in Washington, D.C. Contact James Blanchard at 202/434-7231 for additional information...



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