510(k): Format and Contents 2013 2026 2027 (33103)

Definitions and medical device classification including in vitro diagnostic medical devices
Statute(s) and regulations governing 510(k)
How to identify a suitable predicate device(s), if any
Who should submit 510(k)s and when required to submit 510(k)s
Recent changes in the 510(k) program
How to demonstrate substantial equivalence
Differences in contents of 510(k)s based on products
Decision points during 510(k) review
How to address the relevant and applicable regulatory requirements
How to identify regulatory requirements relevant and applicable to the product(s)
How to increase 510(k) submission quality for a product
How to present your performance data and clinical data in a succinct, comprehensive manner
How to resolve different opinions between the submitter and FDA reviewer(s)
How to respond to FDA’s request of additional information

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510(k): Format and Contents 2013