The FDA clears most medical devices for marketing in the U.S. through the 510(k) process. Companies must file new 510(k)s for new products or changes ..
to existing ones. This raises questions about the 21 mandatory elements, proving substantial equivalence, and documentation. It also addresses IDEs, De Novos, PMAs, and initiating dialog with the FDA under the Q-Submission program. The submission process should include certain information and only reference other aspects. Companies must address new concerns and determine approaches for product and process changes. Additionally, software "in-" or "as-product" and ISO 14971 Risk Management play a role in the submission documentation process.
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