What must be obtained before initiating a clinical investigation for a medical device?

Before initiating a clinical investigation for a medical device, obtaining an Investigational Device Exemption (IDE) is essential. An IDE is a regulatory requirement set by the FDA, allowing a device that is not yet approved for marketing to be used in clinical trials to collect safety and effectiveness data. This exemption ensures that the study complies with relevant regulatory standards and provides protections for the trial participants.

The IDE application must include comprehensive information about the device, including its manufacturing details, how the study will be conducted, and the data collection methods. This process is crucial for ensuring the safety of subjects involved in clinical investigations while facilitating the development of new medical technologies.

Other options serve different regulatory purposes. A Certificate of Compliance pertains to quality system regulations and is not directly related to the initiation of clinical studies. A Pre-Mark Approval (PMA) is required for devices that are intended for commercial distribution after successful clinical trials but does not pertain to the ability to start those trials. A Clinical Trial Authorization (CTA) is relevant in some jurisdictions for drug trials, but in the context of medical devices in the United States, the IDE is the specific requirement that must be satisfied before clinical investigations can commence.