RAS623

Explain the history and purpose of the 510(k) regulation and requirements; including the de novo classification process.

Compare and contrast Traditional 510(k) submission structure and requirements, to 510(k) submission types.

Formulate a technical Substantial Equivalence position with a predicate device.

Identify and interpret regulations, guidance documents, and consensus standards to develop a 510(k) submission plan.

Describe bench and clinical requirements.

Identify and apply strategic planning to QSR-compliant post-market product design and manufacturing changes requiring regulatory assessment.

Identify best practices associated with the operational preparation and timely clearance of Premarket Notifications.

Analyze common additional information (AI) requests and discuss how to avoid them.

Discuss the legal basis of Emergency Use Authorizations (EUAs).