Which of the following is NOT a key medical device submission for marketing permission from the FDA?

The Investigational Device Exemption (IDE) is not a submission for marketing permission; rather, it allows for the clinical investigation of a device that is not yet approved for marketing. The IDE provides a pathway for manufacturers to conduct clinical trials in order to gather data on the safety and effectiveness of a device before seeking formal approval to market it.

In contrast, the other options listed—510(k) submissions, Humanitarian Device Exemption (HDE), and Premarket Approval (PMA)—are key mechanisms for obtaining marketing clearance or approval from the FDA.

The 510(k) process allows manufacturers to demonstrate that their device is substantially equivalent to a legally marketed device. The HDE provides a means for marketing devices intended to benefit patients with rare diseases or conditions, while the PMA process is used for devices that present a higher-risk, requiring rigorous review to ensure safety and effectiveness. Each of these submissions directly pertains to the marketing authorization for medical devices, highlighting why the IDE is distinctly different in its purpose and not considered a submission for marketing permission.