What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. What is the De Novo provision? The US classification system. For clinical trials, an IDE (Investigational Device Exemption) submission is required. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.
What are the required steps and how are they documented? How is 510(k) vs PMA determined. What should be included, and what should only be referenced. What new concerns need to be addressed? The 3 types of 510(k)s and when used. The 21 mandatory elements will be addressed. Tougher requirements, Changed requirements, Software “in-” or “as-product”? How does Product Risk Management fit into the submission process? will also be discussed.
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