Definition of Bundling

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Bundling: A term employed by the FDA (the US Food & Drug Administration) that refers to the inclusion of multiple devices or multiple indications for use for a device in a single premarket submission, including products subject to the device and biologics license application (BLA) authorities, for purposes of review and user fee payment. In CBER, the term may also include the designation of separate submissions as one premarket submission for review and user fee payment. Multiple devices may include different models within a generic type of device or devices that are of differing generic types.