What must a manufacturer demonstrate for a device to be classified as substantially equivalent?

For a device to be classified as substantially equivalent to a predicate device, the manufacturer must demonstrate that it has a similar design and intended use. This concept of substantial equivalence is central to the 510(k) premarket notification process established by the FDA.

To achieve substantial equivalence, the new device must have characteristics that are at least as safe and effective as those of the predicate device already on the market. By showing similarities in design and intended use, the manufacturer demonstrates that the new device can be evaluated in a fashion similar to the predicate, ensuring it does not present any new risks or questions of safety and effectiveness compared to the existing device.

The other options do not reflect the requirements of substantial equivalence accurately. While materials may play a role, being made of the same materials is not a strict requirement; it’s possible for devices with different materials to be substantially equivalent if their performance and safety profiles remain consistent. Cost is not a factor in the determination of substantial equivalence. Lastly, the speed of the approval process isn't a deciding criterion; rather, the focus is on the safety and effectiveness of the device in comparison to the predicate.