If a company modifies its legally marketed device and the change does not affect the intended use or alter the fundamental scientific technology, what should the change be filed as?

Prepare for the RAC Medical Devices Exam. Study with flashcards and multiple choice questions, each question has hints and explanations. Get ready for your exam!

When a company modifies a legally marketed device without affecting its intended use or altering the fundamental scientific technology, the change can be filed as a Special 510(k). This submission pathway is specifically designed for situations where a manufacturer has made modifications to a device that do not entail significant changes to its basic principles or intended purpose.

The Special 510(k) is beneficial because it allows for a streamlined review process, enabling the company to provide a more simplified submission that focuses primarily on the new changes and how they comply with existing FDA standards. This pathway is advantageous for minor modifications, as it helps expedite the time to market while still ensuring regulatory compliance.

On the other hand, other options like the Abbreviated 510(k), Traditional 510(k), and De novo 510(k) typically involve either more significant changes, differ in their submission requirements, or pertain to devices that do not have a suitable predicate for comparison. Therefore, when the modifications do not affect the fundamental characteristics of the device, filing as a Special 510(k) is the most appropriate and efficient route.

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