Which of the following is NOT a key Medical Device submission that directly leads to marketing permission from the FDA?

The Investigational Device Exemption (IDE) is a regulatory submission that allows for the study of a medical device in clinical trials within the United States. It is designed to facilitate the premarket clinical testing of devices to assess their safety and effectiveness before they can be submitted for marketing approval. However, obtaining an IDE does not itself result in marketing permission for the device; it is primarily a means to gather necessary clinical data.

In contrast, the other submissions listed are critical pathways to achieving marketing permission from the FDA. The 510(k) submission allows manufacturers to demonstrate that their device is at least as safe and effective as a legally marketed device (predicate), whereas the Premarket Approval (PMA) process entails a more rigorous review for devices that pose higher risks. The Humanitarian Device Exemption (HDE) allows for marketing of devices intended to treat conditions affecting fewer than 8,000 individuals per year, serving a public health need.

Thus, while the IDE is essential for gathering information needed for later submissions, it does not itself lead to direct marketing permission, making it the correct choice in this context.