Which scenario would trigger Pre-market Notification Requirements for a device?

The scenario that triggers Pre-market Notification Requirements, commonly known as the 510(k) process, is one where the device is substantially equivalent to a pre-amendment device. Pre-amendment devices are those that were on the market prior to the Medical Device Amendments of 1976. If a new device is shown to be substantially equivalent to such a device, it can be marketed without the need for extensive clinical data, as it does not require the same level of scrutiny as a new device.

Substantial equivalence means that the new device has the same intended use and technological characteristics as the pre-amendment device, or has different technological characteristics but does not raise new questions of safety and efficacy. This establishes a streamlined pathway for devices that are comparable to existing products, simplifying the approval process while ensuring safety and effectiveness standards are maintained.

In contrast, scenarios involving devices intended solely for a specific physician or for veterinary use often do not meet the criteria for substantial equivalence applicable under the 510(k) process. Similarly, a device that is not equivalent to currently marketed devices typically would follow a different regulatory pathway, such as the premarket approval (PMA) process, which requires more comprehensive clinical data. Thus, the requirement for a pre