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Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says

Executive Summary

Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.

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