05. Intended Use and Clinical Impact Quizzes

Intended Use and Clinical Impact Quizzes

Intended Use

Which of the following are true about your Intended Use statement?

SOLUTION:
  • The intended use statement should be concise
  • The intended use statement states _what_ your device does
  • The intended use statement is tied directly to your device's risk category

Regulatory Pathways

Which of the following could be a reason why an algorithm would need to go down the PMA pathway with the FDA?

SOLUTION: It is a viewed as medium risk, Class II device, but there is no predicate

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