Which Act emphasizes substantial equivalence for marketing applications of devices?

The FDA Modernization Act of 1997 is significant because it introduced a streamlined approach for the marketing of medical devices through the concept of substantial equivalence. This means that a new device can be marketed if it can be shown to be as safe and effective as a device that is already legally marketed in the U.S. This process is primarily associated with the 510(k) submission pathway, allowing manufacturers to demonstrate that their device is comparable to an existing one without needing to provide extensive clinical data, thereby facilitating faster access to the market while maintaining safety standards.

The other acts mentioned do not specifically focus on the concept of substantial equivalence in the same way. The Food, Drug, and Cosmetic Act establishes the foundation for regulating food and drugs but does not specifically address the streamlined marketing pathway for medical devices. The Health Insurance Portability and Accountability Act primarily focuses on the protection of health information and does not pertain to device marketing. The Food and Drug Administration Safety and Innovation Act, while it includes provisions to improve the process for medical devices and drugs, does not explicitly define or emphasize substantial equivalence in device marketing like the 1997 act does.