Compliance with U.S. rules and regulations
The firm has acquired special expertise in this field over the years and can advise you if your products fall under the regulatory authority of the US Food and Drug Administration (FDA). Some of these products include:
- Medical devices and aids
- Devices that emit electromagnetic waves, such as X-ray machines, microwave ovens, or cell phones
The FDA derives its executive powers from the Federal Food Drug and Cosmetic Act (FD&C Act), and is authorized to issue administrative provisions to facilitate the exercise of these powers. The FDA’s administrative procedures are complex and compliance with them must be correctly documented. Errors or omissions in the documentation can cost valuable time and hence your potential competitive advantage in the market. Our specialist lawyers are in touch with the relevant contacts at the authorities and make the FDA procedure faster, more transparent, and most cost-effective for your company.