What does the term ‘substantial equivalence’ indicate in relation to medical devices?

The concept of 'substantial equivalence' is a key criterion used by regulatory bodies, such as the U.S. Food and Drug Administration (FDA), to evaluate new medical devices. When a device is determined to be substantially equivalent, it signifies that the device is comparable in terms of safety and effectiveness to a legally marketed device (the predicate device). This evaluation allows the new device to be marketed without the need for the extensive clinical testing typically required for a new device classification.

Substantial equivalence does not imply that the new device is superior to the existing ones; rather, it indicates that it performs similarly to a device that is already available, which helps demonstrate that the device can be safely used by consumers. Therefore, substantial equivalence focuses on ensuring that any potential risks have been mitigated to levels comparable to existing products.

The other choices provided do not reflect the accurate meaning of substantial equivalence. For instance, claiming that a device is patented does not directly relate to its safety or efficacy compared to existing devices. Similarly, stating that a device is easier to manufacture does not address its clinical performance or risk profile compared to a predicate device.