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# Changes Suggested for Bridging Guidance
- URL: https://www.fdaweb.com/changes-suggested-for-bridging-guidance/
- Published: 2020-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:11:14.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146562

Two stakeholders are suggesting changes in an FDA draft guidance on bridging for drug-device and biologic-device combinations. AdvaMed’s comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-5585-0010&ref=fdaweb.com) commends the agency for implementing the guidance and offers “minor revisions to improve the clarity and impact” of the document.

The Biotechnology Innovation Organization [says](https://www.regulations.gov/document?D=FDA-2019-D-5585-0011&ref=fdaweb.com) the draft guidance “presents a reasonable approach to bridging for combination products.” The letter also gives the association’s line-by-line suggestions for changes before the guidance is finalized.