Which of the following is NOT a type of regulatory submission for medical devices?

The correct choice is the one that identifies an option not recognized as a regulatory submission type for medical devices. The designation "TMD (Tactical Medical Device)" is not an established term within U.S. regulatory frameworks such as the FDA.

In the context of medical device regulation, the Premarket Approval (PMA) and the 510(k) Submission are well-defined processes. The PMA process is required for high-risk devices that must undergo rigorous evaluation for safety and effectiveness before they can be marketed, while the 510(k) Submission allows manufacturers to demonstrate that their device is substantially equivalent to a previously cleared device.

The term "SDA" does not align with formally recognized submission pathways. Instead, the appropriate terminology in regulatory frameworks would be PMA, 510(k), and possibly others like De Novo classification, but not "SDA." The focus on understanding and recognizing valid regulatory terms is essential for navigating medical device regulations effectively.