Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.
PMID: 35288821 ·
Aaron E Lottes, Kenneth J Cavanaugh, Yvonne Yu-Feng Chan, Vincent J Devlin, Craig J Goergen, Ronald Jean, Jacqueline C Linnes, Misti Malone, Raquel Peat, David G Reuter, Kay Taylor, George R Wodicka
Abstract
Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators. A mult
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