Company: DHR
Filing Date: 2025-02-20
Form Type: 10-K
Source: 0000313616-25-000043
Chunk: 89

Company: DANAHER CORP /DE/
Filing Date: 2025-02-20
Form: 10-K
Item: Item 1
Chunk 89
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 institutions, universities and clinicians around the world to develop, evaluate and clinically test our products.  The Company conducts R&D activities primarily in North America, Europe and Asia and generally on a business-by-business basis.  The Company anticipates that it will continue to make significant expenditures for R&D as it seeks to provide a continuing flow of innovative products and services to maintain and improve its competitive position.  For a discussion of the risks related to the need to develop and commercialize new products and product enhancements, refer to “Item 1A. Risk Factors.” 

Government Contracts

Although the substantial majority of the Company’s revenue in 2024 was from customers other than governmental entities, each of Danaher’s segments has agreements relating to the sale of products to government entities.  As a result, the Company is subject to various statutes and regulations that apply to companies doing business with governments.  For a discussion of risks related to government contracting requirements, refer to “Item 1A. Risk Factors.”  No material portion of Danaher’s business is subject to renegotiation of profits or termination of contracts at the election of a government entity. 

9

Regulatory Matters

The Company faces extensive government regulation both within and outside the United States relating to its operations, including the development, manufacture, marketing, sale and distribution of its products and services.  The following sections describe certain significant regulations that the Company is subject to.  These are not the only regulations that the Company’s businesses must comply with.  For a description of the risks related to the regulations that the Company’s businesses are subject to, refer to “Item 1A. Risk Factors.”

Medical Device Regulations

Many of our products are classified as medical devices and are subject to restrictions under domestic and foreign laws, rules, regulations, self-regulatory codes, circulars and orders, including, but not limited to, the U.S. Food, Drug, and Cosmetic Act (the “FDCA”).  The FDCA requires these products, when sold in the United States, to be safe and effective for their intended uses and to comply with the regulations administered by the U.S. Food and Drug Administration (“FDA”).  The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, packaging, marketing, distribution, import and export and record keeping for such products.  Many medical device products are also regulated by comparable agencies in non-U.S. countries in which they are produced or sold.

Unless an exemption applies, the