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# Combination Product Pathway Guidance
- URL: https://www.fdaweb.com/combination-product-pathway-guidance/
- Published: 2019-02-06T12:00:00.000Z
- Updated: 2026-09-15T01:00:49.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143315

FDA has issued a draft guidance, *Principles of Premarket Pathways for Combination Products*, to provide the agency’s current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. “This [guidance](https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM630458.pdf?ref=fdaweb.com) offers general, high-level information relevant to combination products,” it says. The document notes that FDA has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types of combination products.