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# Final Guide on Combo Product Safety Reporting
- URL: https://www.fdaweb.com/final-guide-on-combo-product-safety-reporting/
- Published: 2019-07-22T12:00:00.000Z
- Updated: 2026-09-15T01:39:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144589

FDA has released a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-combination-products?utm%5Fcampaign=072219%5FFIB%5FFDA%20reinforces%20need%20to%20submit%20timely%20combination%20products%20safety%20info&utm%5Fmedium=email&utm%5Fsource=Eloqua) on “Postmarketing Safety Reporting for Combination Products.” The document addresses how to comply with a 2016 final rule on postmarketing safety reporting (PMSR) requirements for combination products. “Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes,” FDA says. “The final rule addresses the application of these regulatory requirements to combination products to ensure consistent and complete reporting while avoiding duplication.”