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# PhRMA Wants Combination Product Guidance Clarified
- URL: https://www.fdaweb.com/phrma-wants-combination-product-guidance-clarified/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:41.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5144077

Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to clarify a draft guidance on principles of premarket pathways for combination products. The association [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-D-0078-0009&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) that while it appreciates the agency’s efforts to clarify the premarket pathways for combination products and implement provisions of the 21st Century Cures Act, additional guidance and clarity is needed on a number of issues. PhRMA asks that the draft guidance be revised to: 

- clarify when the agency believes a single application for a combination product is necessary and when multiple applications for the constituent parts of a combination product are appropriate;
- address the premarket review of combination products reviewed under separate applications;
- clarify when the agency proposes to expect a single application that is not based on the primary mode of action of the combination product;
- clarify FDA’s data expectations for non-lead constituent parts and address issues regarding combination products that incorporate previously approved, licensed, or cleared constituent parts;l
- modify the discussion regarding the availability of the 510(k) premarket notification pathway for device-led combination products;
- clarify how the agency will evaluate the intended use of combination products; and
- clarify the relationship between the discussion in the draft guidance addressing a generic drug-device combination product subject to an ANDA and other agency guidance on that topic.