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# Changes Sought in Draft Combination Product Bridging Guidance
- URL: https://www.fdaweb.com/changes-sought-in-draft-combination-product-bridging-guidance/
- Published: 2020-02-18T12:00:00.000Z
- Updated: 2026-09-14T16:03:22.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146110

Boehringer Ingelheim says the three case study examples in an FDA draft guidance on bridging for drug-device and biologic-device combination products are helpful in illustrating the stepwise approach described in the guidance. However, the company [comment](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-D-5585-0006&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that with the understanding that the three cases describe different scenarios, the examples are not entirely consistent with respect to the gap analysis, wording, and terms used. It recommends that the text be revised to bring the three examples into closer alignment with each other.

The letter includes additional general and line-by-line specific comments.