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12 Jan 2024Ended

The 510(k), IDE, Q-Sub, De Novo, and PMA Submission and Approval Process

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Timings

09:00 AM - 06:00 PM
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Website  •  Contacts

Estimated Turnout

100 - 500
Delegates
Based on previous editions

Editions

Jan 2024
+1 more edition

Frequency

Quarterly
Next edition likely in Apr 2024
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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 .. Read more 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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