Question

All of the following regulatory requirements apply to an investigation of a HUD consistent with the HDE approved indication(s), EXCEPT:
Human subject protection requirements.
Financial disclosure requirements.
HIPAA authorization requirements.
Investigational Device Exemption requirements.

Answer 1

Answer:

The correct option is D) Investigational Device Exemption requirements

Explanation:

An Investigational Device Exemption allows the usage of an investigatory device for safety and collecting effective data which is required for premarket approval. Clinical evaluation for devices that have not been used for marketing requires an Investigational Device Exemption (IDE) approved by the institutional review board (IRB). Investigations which are done under the IDE regulation require different regulatory controls according to the level of risk.