bundling
- Guideline or reference source
- CDRH Center for Devices & Radiological Health, FDA, Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission, 2003
- WHO Glossary
- Definition
- 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 device2 or devices that are of differing generic types. Bundling is a marketing strategy that involves offering several products for sale as one combined product.
- Narrower Term
- combination pack
- Related Term
- combination product
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