RAC (Devices) Practice Questions - Regulatory Affairs Certification - Devices Exam

The De Novo classification pathway is most appropriate for which type of device?

A high-risk Class III device requiring clinical trials A device identical to an existing legally marketed predicate A device being studied under an investigational protocol A novel low-to-moderate risk device with no valid predicate

Correct Answer:

A novel low-to-moderate risk device with no valid predicate

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