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# Comments on Combination Product Draft Guidance
- URL: https://www.fdaweb.com/comments-on-combination-product-draft-guidance/
- Published: 2020-02-27T12:00:00.000Z
- Updated: 2026-09-14T16:04:52.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146193

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to clarify through draft guidance the appropriate mechanisms and pathways for combination product sponsors to obtain agency feedback, including the inclusion of best practices regarding interactions between FDA and combination product sponsors. “While PhRMA appreciates the inclusion of these best practices,” a comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-4739-0012&ref=fdaweb.com) says, “PhRMA notes that many of these practices are not specific to interactions regarding combination products. PhRMA suggests that FDA reference existing guidance on meetings and interactions between sponsors and FDA, which outline these best practices, thereby allowing FDA to refocus the section on best practices that are unique to interactions regarding combination products.”

In its [comment](https://www.regulations.gov/document?D=FDA-2019-D-4739-0008&ref=fdaweb.com), AdvaMed says the guidance could be improved by additional attention to combination product convenience kits and by mechanisms for non-primary mode of action device makers to receive FDA feedback.

Both stakeholders also offer specific line-by-line comments.