De Novo Applications is a regulatory pathway in the United States for medical devices that are considered "novel" and do not have a predicate device on the market to which they can be compared.

In the past, manufacturers of new medical devices that did not have a predicate device had to go through the more stringent Premarket Approval (PMA) pathway, which required extensive clinical testing and review by the FDA. However, in 1997, the FDA created the De Novo pathway to provide an alternative for novel medical devices that were deemed to pose a low to moderate risk to patients.

Investigational Device Exemptions (IDE) is a regulatory pathway in the United States for medical devices that are being evaluated in clinical studies to determine their safety and efficacy.

Before a medical device can be studied in humans, the device must be approved by the FDA for use in clinical investigations under an IDE. The IDE application must include detailed information about the device, the clinical study design, and the patient population that will be enrolled in the study.

Premarket Approval (PMA) is a regulatory pathway in the United States for high-risk medical devices that have not yet been approved by the FDA for marketing and commercial distribution.

PMA is the most rigorous and comprehensive regulatory pathway for medical devices, requiring extensive clinical data and evidence to demonstrate the safety and effectiveness of the device for its intended use. The PMA application must include detailed information about the device's design, manufacturing, testing, clinical studies, labeling, and potential risks and benefits.

Pre-Submission Dossiers, also known as Pre-Subs, is a voluntary regulatory pathway in the United States that allows medical device manufacturers to interact with the FDA before submitting a formal application for clearance or approval.

Pre-Subs are intended to help manufacturers better understand the FDA's expectations for regulatory submissions and to get feedback on the design of the clinical studies needed to support clearance or approval. The manufacturer submits a written request to the FDA that outlines the questions or issues they would like to discuss, and the FDA provides written feedback in response.