Cancer Terms

Investigational Device Exemption

Cancer Terms -> Conceptual Entities -> Exemption -> Investigational Device Exemption

Investigational Device Exemption Definition

Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.

Investigational Device Exemption Synonyms

Investigational Device Exemption

Terms in Investigational Device Exemption category

Investigational Device-Exemption 520 L
Investigational Device Exemption 520 G CDRH



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