Combination Product Regulatory Fairness Act of 2016

[AI summary unavailable — showing source text] Combination Product Regulatory Fairness Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination. If the FDA preliminarily determines that a product is not a medical device, the sponsor may propose a study to inform the product's classification. The FDA is prohibited from determining that a combination product (a product that is a combination of drug, device, or biological product) is a drug solely because the product has a chemical action. The FDA must provide the scientific rationale for deciding the primary mode of action (the most important therapeutic action) of a combination product if the FDA's decision disagrees with the conclusions of the product sponsor. (Combination products are regulated based on their primary mode of action.) The sponsor of a combination product and the FDA may agree to a combination product review plan regarding the standards and requirements applicable to the product's premarket review, postmarket modification, or manufacturing. …