The Medical Devices Act of 1976 was a significant legislative milestone that established a framework for the regulation of medical devices to ensure their safety and effectiveness before they could be marketed to the public. The Act mandated that manufacturers provide sufficient evidence showing that their medical devices are safe for use and effective in performing intended functions. This requirement is foundational in protecting public health, as it ensures that devices that pose potential health risks are evaluated for their performance and safety prior to being available in the marketplace.
In the context of the other statements, they do not align with the intent or stipulations of the Medical Devices Act. Marketing devices without testing undermines safety standards and could lead to dangerous outcomes. The classification of devices serves as a risk assessment mechanism, but the Act primarily emphasizes the need for proof of safety and effectiveness. Lastly, stating that devices should not be regulated contradicts the very purpose of the Medical Devices Act, which is to provide oversight and regulation to safeguard public health. Thus, the correct indication of the Act is the requirement for all devices to be demonstrated as safe and effective before marketing.