MEDICAL DICTIONARY
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.
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