Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

paythelady.61 shared this article with you from Inoreader Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts Via Latest Results for Journal of Cardiovascular Translational Research 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 multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a revi ew of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders. Graphical abstract Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.