SOLV: 10-K Risk Factor Changes

The products Solventum develops, manufactures, and commercializes are regulated in most of the markets Solventum serves. Some of these products meet the definition of medical devices, pharmaceuticals or combination products and are regulated, as such, by various governmental bodies, globally. All products produced by the MedSurg and Dental Solutions segments, with 10 10 10 10 10 10 Table of Contents Table of Contents Table of Contents very few exceptions, meet the definition of a medical device or pharmaceutical product. Accordingly, the development, manufacture, and commercialization of these products must comply with the regulations governing medical devices or pharmaceuticals in the markets we serve. Conversely, none of the products produced by the Health Information Systems segment meet the definition of medical devices or pharmaceuticals. The product portfolio of the segment is dynamic and changes with time, depending on the needs of the customers served. While the Health Information Systems segment does not currently include medical devices or pharmaceutical products, this may change in the future. Determinations of the safety and efficacy of our products are solely within the authority of the United States Food and Drug Administration ("FDA") or other applicable regulatory authorities in jurisdictions outside the United States.