Final answer:
In the context of FDA regulatory filings for a device modification that doesn't change intended use or scientific technology and where design output meets input requirements, a Special 510(k) filing is most appropriate.
Step-by-step explanation:
The question is regarding regulatory filings for medical devices with the U.S. Food and Drug Administration (FDA). Specifically, the scenario describes a company wishing to modify an existing legally marketed device where the modification does not change the intended use or the fundamental scientific technology and design outputs meet design input requirements. The appropriate type of filing for this scenario would be a Special 510(k).
The FDA's 510(k) program has different pathways depending on the nature of the device modification, including Special, Abbreviated, and Traditional 510(k). A Special 510(k) is suitable when a change does not affect the intended use or the fundamental scientific technology. In contrast, the Abbreviated 510(k) process is used when the manufacturer can demonstrate conformity with certain FDA-recognized consensus standards, or FDA guidance documents, and the Traditional 510(k) is for most other devices not eligible for the Special or Abbreviated pathways. Lastly, the De novo 510(k) process is for new devices of low to moderate risk that are not substantially equivalent to an already legally marketed device.
Therefore, for a minor modification that meets the criteria outlined, the Special 510(k) is the best filing type.