An innovative product alone is not enough to enter the U.S. market – without proper product approval, access remains closed. The U.S. has complex and stringent requirements, overseen by different agencies depending on the industry. Whether FDA, EPA, FCC, or CPSC – mistakes in this process can lead not only to delays, but also to significant costs and legal risks.
We support German and European companies with all matters related to approval, registration, and labeling of products in the U.S.. Our approach combines legal expertise with a deep understanding of industry-specific requirements – from medical devices, food, and cosmetics to electronics and consumer goods.
Successful approval means more than simply meeting regulatory requirements – it is your ticket to the world’s largest consumer market. We help ensure legal certainty, accelerate market entry, and minimize risks.
Our services in U.S. product approval include:
- Advice on industry-specific requirements (e.g., FDA, EPA, FCC, CPSC)
- Assistance with registration and approval procedures
- Guidance on labeling and packaging requirements
- Review of safety standards and compliance obligations
- Representation in dealings with U.S. authorities and certification bodies
- Legal support in case of objections, recalls, or sanctions