The regulatory process by which the U.S. Food and Drug Administration (FDA) evaluates the safety and effectiveness of Class III medical devices before they are allowed to be marketed and sold in the United States.

Class III Medical Device:

A category of medical devices, as classified by the FDA, that are considered high-risk and intended for supporting or sustaining human life, or presenting a potential unreasonable risk of illness or injury.

FDA Regulation:

The oversight and enforcement of laws and regulations by the U.S. Food and Drug Administration (FDA) to ensure the safety, efficacy, and quality of medical products, including devices, drugs, and biologics.

Clinical Trial:

A research study involving human participants to evaluate the safety and efficacy of medical devices, treatments, or interventions before they are approved for widespread use.

Investigational Device Exemption (IDE):

Permission granted by the FDA to conduct clinical trials of investigational medical devices in humans, allowing them to be used in research under specified conditions.

Safety and Efficacy:

The assessment of a medical device’s ability to produce the desired therapeutic effect while minimizing the risk of adverse events or harm to patients.

Premarket Notification (510(k)):

A regulatory pathway for certain medical devices to demonstrate substantial equivalence to a legally marketed device that does not require PMA, allowing them to be cleared for marketing by the FDA.

Device Classification:

The categorization of medical devices by the FDA based on their intended use, indications for use, and level of risk to patients and users.

Labeling Requirements:

The information, instructions, and warnings provided with medical devices, including labels, package inserts, and user manuals, to ensure safe and proper use.